MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY (BD) BD VACUTAINER® 9NC 0.109M BUFFERED TRISODIUM CITRATE PLUS BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number	363047
Medical Device Problem Codes	Clumping in Device or Device Ingredient (1095); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported when using the bd vacutainer® 9nc 0.109m buffered trisodium citrate plus blood collection tubes, the device experienced clogged / blocked instrument probe.The following information was provided by the initial reporter.The customer stated: a tp/tck/fib/dd was requested by the emergency department.Our sta-r max ii automated system returned all parameters without alarm on the blocked primary tube.All results were normal all results were normal except the pt which was very low (28%) for a patient not taking any anticoagulant treatment.The lowered pt result was checked and the machine returned the same value (31%) for the second assay, again from the blocked primary tube.Primary tube.After discussion with the emergency physician, we decided to add a complete liver work-up, an alcohol level and the determination of factors ii, v, vii and viii.Factors ii, v, vii and x.The doctor wanted the full work-up in order to be able to hospitalise his patient in a context of shortage of hospital places.Beforehand, we took the primary tube out of the machine and aliquoted it.The factors were therefore measured on an aliquot: all the factors came back normal.We looked for the presence of we looked for the presence of a possible direct oral anticoagulant which could have explained this discrepancy between a lowered pt and normal factors but this hypothesis came back negative.But this hypothesis came back negative.We then repeated the pt assay on the aliquot a third time: the result came back 99% normal.We checked the result again with a 4th assay on the aliquot: the result again came back normal at 100%.When we saw that it was a bd tube, we observed the cap of the tube: the polymer has a star-shaped deformation on the inside of the tube like this when we saw that it was a bd tube, we looked at the cap of the tube: the polymer has a star-shaped deformation on the inside of the tube like what can be seen with a stone on a windscreen.It is likely that it is likely that the elastomer is too rigid and bursts under the pressure of the needle instead of deforming when the needle first enters the tube.Into the tube.In addition, the clamp of the sampling needle of the automated system is again filled with debris from the blue cap of bd tubes.This debris this debris is also found stuck along the sampling needle and on the mats holding the racks inside the machine.The machine.
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
B.5.Event description : it was reported when using the bd vacutainer® buffered trisodium citrate plus blood collection tubes, the device experienced a clogged instrument resulting in erroneous results.The following information was provided by the initial reporter.The customer stated: a tp/tck/fib/dd was requested by the emergency department.Our sta-r max ii automated system returned all parameters without alarm on the blocked primary tube.All results were normal all results were normal except the pt which was very low (28%) for a patient not taking any anticoagulant treatment.The lowered pt result was checked and the machine returned the same value (31%) for the second assay, again from the blocked primary tube.Primary tube.After discussion with the emergency physician, we decided to add a complete liver work-up, an alcohol level and the determination of factors ii, v, vii and viii.Factors ii, v, vii and x.The doctor wanted the full work-up in order to be able to hospitalise his patient in a context of shortage of hospital places.Beforehand, we took the primary tube out of the machine and aliquoted it.The factors were therefore measured on an aliquot: all the factors came back normal.We looked for the presence of we looked for the presence of a possible direct oral anticoagulant which could have explained this discrepancy between a lowered pt and normal factors but this hypothesis came back negative.But this hypothesis came back negative.We then repeated the pt assay on the aliquot a third time: the result came back 99% normal.We checked the result again with a 4th assay on the aliquot: the result again came back normal at 100%.When we saw that it was a bd tube, we observed the cap of the tube: the polymer has a star-shaped deformation on the inside of the tube like this when we saw that it was a bd tube, we looked at the cap of the tube: the polymer has a star-shaped deformation on the inside of the tube like what can be seen with a stone on a windscreen.It is likely that it is likely that the elastomer is too rigid and bursts under the pressure of the needle instead of deforming when the needle first enters the tube.Into the tube.In addition, the clamp of the sampling needle of the automated system is again filled with debris from the blue cap of bd tubes.This debris this debris is also found stuck along the sampling needle and on the mats holding the racks inside the machine.The presence of bd haemostasis cap debris inside our 2 sta-r max ii machines has been reported to the supplier.A month ago with photos of the anomalies observed.Imdrf annex a grid : a0908.
Event or Problem Description
It was reported when using the bd vacutainer® 9nc 0.109m buffered trisodium citrate plus blood collection tubes, the device experienced clogged / blocked instrument probe causing erroneous results.The following information was provided by the initial reporter.The customer stated: a tp/tck/fib/dd was requested by the emergency department.Our sta-r max ii automated system returned all parameters without alarm on the blocked primary tube.All results were normal all results were normal except the pt which was very low (28%) for a patient not taking any anticoagulant treatment.The lowered pt result was checked and the machine returned the same value (31%) for the second assay, again from the blocked primary tube.Primary tube.After discussion with the emergency physician, we decided to add a complete liver work-up, an alcohol level and the determination of factors ii, v, vii and viii.Factors ii, v, vii and x.The doctor wanted the full work-up in order to be able to hospitalise his patient in a context of shortage of hospital places.Beforehand, we took the primary tube out of the machine and aliquoted it.The factors were therefore measured on an aliquot: all the factors came back normal.We looked for the presence of we looked for the presence of a possible direct oral anticoagulant which could have explained this discrepancy between a lowered pt and normal factors but this hypothesis came back negative.But this hypothesis came back negative.We then repeated the pt assay on the aliquot a third time: the result came back 99% normal.We checked the result again with a 4th assay on the aliquot: the result again came back normal at 100%.When we saw that it was a bd tube, we observed the cap of the tube: the polymer has a star-shaped deformation on the inside of the tube like this when we saw that it was a bd tube, we looked at the cap of the tube: the polymer has a star-shaped deformation on the inside of the tube like what can be seen with a stone on a windscreen.It is likely that it is likely that the elastomer is too rigid and bursts under the pressure of the needle instead of deforming when the needle first enters the tube.Into the tube.In addition, the clamp of the sampling needle of the automated system is again filled with debris from the blue cap of bd tubes.This debris this debris is also found stuck along the sampling needle and on the mats holding the racks inside the machine.The machine.
Event or Problem Description
It was reported when using the bd vacutainer® 9nc 0.109m buffered trisodium citrate plus blood collection tubes, the device experienced clogged / blocked instrument probe causing erroneous results.The following information was provided by the initial reporter.The customer stated: a tp/tck/fib/dd was requested by the emergency department.Our sta-r max ii automated system returned all parameters without alarm on the blocked primary tube.All results were normal all results were normal except the pt which was very low (28%) for a patient not taking any anticoagulant treatment.The lowered pt result was checked and the machine returned the same value (31%) for the second assay, again from the blocked primary tube.Primary tube.After discussion with the emergency physician, we decided to add a complete liver work-up, an alcohol level and the determination of factors ii, v, vii and viii.Factors ii, v, vii and x.The doctor wanted the full work-up in order to be able to hospitalise his patient in a context of shortage of hospital places.Beforehand, we took the primary tube out of the machine and aliquoted it.The factors were therefore measured on an aliquot: all the factors came back normal.We looked for the presence of we looked for the presence of a possible direct oral anticoagulant which could have explained this discrepancy between a lowered pt and normal factors but this hypothesis came back negative.But this hypothesis came back negative.We then repeated the pt assay on the aliquot a third time: the result came back 99% normal.We checked the result again with a 4th assay on the aliquot: the result again came back normal at 100%.When we saw that it was a bd tube, we observed the cap of the tube: the polymer has a star-shaped deformation on the inside of the tube like this when we saw that it was a bd tube, we looked at the cap of the tube: the polymer has a star-shaped deformation on the inside of the tube like what can be seen with a stone on a windscreen.It is likely that it is likely that the elastomer is too rigid and bursts under the pressure of the needle instead of deforming when the needle first enters the tube.Into the tube.In addition, the clamp of the sampling needle of the automated system is again filled with debris from the blue cap of bd tubes.This debris this debris is also found stuck along the sampling needle and on the mats holding the racks inside the machine.The machine.
Additional Manufacturer Narrative
H.6 investigation summary bd received 6 photographs from the customer in support of this complaint.The photos were evaluated and revealed the following: 1.Blue stopper pieces on the piece of equipment.2.A piece of equipment and, 3.A stopper with a black foreign matter on it.It is difficult to determine the foreign matter from the photos provided.Additionally, 10 retention tubes from the bd inventory were evaluated and there were no issues observed relating to foreign matter.This complaint is confirmed for foreign matter based oh the photo evidence provided however, the issue was not observed in the evaluation of the retention sampling.Bd was unbale to determine a root cause for the issue of foreign matter.Additionally, 12 retention samples from the bd inventory were functionally tested for the issue of erroneous results.No difficulties were encountered during blood collection and all tubes appeared to exhibit proper fill.Bd was unable to duplicate or confirm the customer¿s indicated failure (erroneous results) because the defect was not evident in the testing of the complaint lot samples.Replicates of both retain and control samples were acceptable in terms of both precision and accuracy (validation attached).Laboratory analysis of retain and control samples demonstrated clinically acceptable performance for all visual observations evaluated.The citrate tubes performed as expected.This complaint is unconfirmed for erroneous results.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.There were no related quality issues during manufacturing of the product.This complaint is unable to be confirmed for the indicated failure modes foreign matter or erroneous results.Bd was not able to identify a root cause for the indicated failure mode.Factors that may contribute to the indicated issues were evaluated through a clinical study to verify the design of the device met it¿s intended use.The result of the study showed that the device performed as expected and we were unable to determine any external contributor to this reported issue.

• Brand Name: BD VACUTAINER® 9NC 0.109M BUFFERED TRISODIUM CITRATE PLUS BLOOD COLLECTION TUBES
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth ; UK
• Manufacturer (Section G): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth ; UK
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14322184
• Report Number: 9617032-2022-00455
• Device Sequence Number: 4697748
• Product Code: JKA
• UDI-Device Identifier: 00382903630479
• UDI-Public: 00382903630479
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K013971
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 05/31/2022
• Device Catalogue Number: 363047
• Device Lot Number: 1326306
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2022
• Supplement Date Received by Manufacturer: 05/09/2022; 08/25/2022
• Initial Report FDA Received Date: 05/07/2022
• Supplement Report FDA Received Date: 05/09/2022; 09/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/22/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown