MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® SODIUM FLUORIDE 15MG POTASSIUM OXALATE 12 MG(FX) COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number	367925
Medical Device Problem Codes	Coagulation in Device or Device Ingredient (1096); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510(k) #: k945952, k901449.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that bd vacutainer® sodium fluoride 15 mg potassium oxalate 12 mg(fx) collection tubes was clotting and giving erroneous results.No serious injury or medical intervention was reported.The following information was provided by the initial reporter: material no.367925, batch no.8215742.''the customer would like to know what they are doing wrong because they are seeing what looks like coagulation and precipitation once the plasma is pulled and the sample sits.Doesn't believe that it's an issue with the product.'' during the validation of the grey tops the customer is seeing what looks like coagulation and precipitation once the plasma is pulled and does not spin down well.In there study they have noticed a negative bias.Agilent 7890 gas chromatograph.Date of event is unknown.Quantity is unknown.
Additional Manufacturer Narrative
H.6.Investigation summary: bd had not received samples, but photos were provided by the customer facility for investigation.The photos were evaluated and a pooled plasma specimen exhibiting a cloudy appearance was observed.A review of the device history record was completed for the incident lot and, based on this review, all product specifications and requirements for lot release were met; there were no related quality non-conformances during manufacturing of the product.Bd had reached out to the customer and provided troubleshooting related to the issue they were observing.The customer reported refrigeration of the specimens, which in many instances will facilitate fibrin formation in plasma.Bd has recommended that the customer use the bd no additive tubes (catalog 366408) and analyze un-pooled specimens.H3 other text : see section h.10.
Event or Problem Description
It was reported that bd vacutainer® sodium fluoride 15mg potassium oxalate 12 mg(fx) collection tubes was clotting and giving erroneous results.No serious injury or medical intervention was reported.The following information was provided by the initial reporter: material no.367925 batch no.8215742.**the customer would like to know what they are doing wrong because they are seeing what looks like coagulation and precipitation once the plasma is pulled and the sample sits.Doesn't believe that it's an issue with the product** during the validation of the grey tops the customer is seeing what looks like coagulation and precipitation once the plasma is pulled and does not spin down well.In there study they have noticed a negative bias.Agilent 7890 gas chromatograph.Date of event is unknown.Quantity is unknown.
Additional Manufacturer Narrative
Correction: the date of event is unknown.The date 4/1/2019 that was reported initially is the date received by manufacturer.B.3.Date of event: unknown.The date received by manufacturer has been used for this field.
Event or Problem Description
It was reported that bd vacutainer® sodium fluoride 15mg potassium oxalate 12 mg(fx) collection tubes was clotting and giving erroneous results.No serious injury or medical intervention was reported.The following information was provided by the initial reporter: material no.367925 batch no.8215742.The customer would like to know what they are doing wrong because they are seeing what looks like coagulation and precipitation once the plasma is pulled and the sample sits.Doesn't believe that it's an issue with the product.During the validation of the grey tops the customer is seeing what looks like coagulation and precipitation once the plasma is pulled and does not spin down well.In there study they have noticed a negative bias.Agilent 7890 gas chromatograph.Date of event is unknown.Quantity is unknown.

• Brand Name: BD VACUTAINER® SODIUM FLUORIDE 15MG POTASSIUM OXALATE 12 MG(FX) COLLECTION TUBES
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• MDR Report Key: 8518525
• Report Number: 1917413-2019-01182
• Device Sequence Number: 11138341
• Product Code: JKA
• UDI-Device Identifier: 50382903679251
• UDI-Public: 50382903679251
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: SEE H.10
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 01/31/2020
• Device Catalogue Number: 367925
• Device Lot Number: 8215742
• Initial Date Received by Manufacturer: 04/01/2019
• Supplement Date Received by Manufacturer: 04/01/2019; 04/01/2019
• Initial Report FDA Received Date: 04/16/2019
• Supplement Report FDA Received Date: 08/29/2019; 08/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other