MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY (BD) BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Model Number 367957

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Device Ingredient or Reagent Problem (2910)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/20/2022

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported when using the bd vacutainer® sst¿ ii advance plus blood collection tube there was erroneous results and hemolysis.The erroneous results event occurred 2 times.The hemolysis event occurred 1 time.The following information was provided by the initial reporter.The customer stated: "blood was taken from one patient in two sst ii advance test tubes cat.No.367957.Considering that once before we had an outage in the results of ck in two tubes of the same patient, we did ck in both tubes.An analytical check of the device was made in such a way that the samples were analyzed with other vials of reagents.The samples were also sent to out, where the same results were obtained.In addition to ck, ckmb was also created.Because of the hemolysis in one tube we agreed that they will let me know if they run into a similar situation.I received information that it happened again.I now realize that i should have sent the pir immediately.Apologizing for the wrong reaction while receiving the first inquiry.".

Event Description

It was reported when using the bd vacutainer® sst¿ ii advance plus blood collection tube there was erroneous results and hemolysis.The erroneous results event occurred 2 times.The hemolysis event occurred 1 time.The following information was provided by the initial reporter.The customer stated: "blood was taken from one patient in two sst ii advance test tubes cat.No.367957.Considering that once before we had an outage in the results of ck in two tubes of the same patient, we did ck in both tubes.An analytical check of the device was made in such a way that the samples were analyzed with other vials of reagents.The samples were also sent to out, where the same results were obtained.In addition to ck, ckmb was also created.Because of the hemolysis in one tube we agreed that they will let me know if they run into a similar situation.I received information that it happened again.I now realize that i should have sent the pir immediately.Apologizing for the wrong reaction while receiving the first inquiry.".

Manufacturer Narrative

H.6.Investigation summary: bd had not received samples, but 1 photo was provided for investigation.The photo was reviewed and the indicated failure mode for erroneous results and hemolysis was not observed.Additionally, retention samples of the incident lot were selected from bd inventory for evaluation and upon completion, no issues relating to erroneous results and hemolysis were observed.There were no difficulties encountered during blood collection and all tubes appeared to exhibit proper fill.Bd was unable to duplicate the customer¿s indicated failure mode (erroneous results-ckmb, hemolysis) 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.All visual observations of both retain and control samples tested demonstrated clinically acceptable performance.All tubes performed as expected.Bd does not have the capability to evaluate ck via clinical investigation at this time.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 mode erroneous results and hemolysis.Bd was not able to identify a root cause for the indicated failure mode.Factors that may contribute to erroneous results and hemolysis 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® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES
• Type of Device: 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: 15986860
• MDR Text Key: 307931886
• Report Number: 9617032-2022-01269
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903679572
• UDI-Public: 50382903679572
• Combination Product (y/n): N
• Reporter Country Code: HR
• PMA/PMN Number: BK050036
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/28/2023

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
• Device Operator: Other
• Device Model Number: 367957
• Device Catalogue Number: 367957
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/21/2022
• Initial Date FDA Received: 12/15/2022
• Supplement Dates Manufacturer Received: 03/28/2023
• Supplement Dates FDA Received: 04/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1