MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) SEE H.10; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number	367925
Medical Device Problem Code	Coagulation in Device or Device Ingredient (1096)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device brand name: bd vacutainer® sodium fluoride 15 mg potassium oxalate 12 mg (fx) blood collection tubes.Pma 510(k) #: k945952, k901449.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that 500 bd vacutainer® sodium fluoride 15 mg potassium oxalate 12 mg (fx) blood collection tubes experienced clotting/micro clots.The following information was provided by the initial reporter: material no.367925, batch no.8156799.We have used your gray top tubes for numerous studies over many years, but just recently have experienced clotting issues.The lot # is 8156799 with an expiration 2019-11-30.
Event or Problem Description
It was reported that 500 bd vacutainer® sodium fluoride 15mg potassium oxalate 12 mg (fx) blood collection tubes experienced clotting/micro clots.The following information was provided by the initial reporter: material no.367925; batch no.8156799.We have used your gray top tubes for numerous studies over many years, but just recently have experienced clotting issues.The lot # is 8156799 with an expiration 2019-11-30.
Additional Manufacturer Narrative
Investigation summary: bd received samples from the customer facility for investigation.The samples, along with retention samples selected from bd inventory, were evaluated and no issues were observed relating to clotting as all samples met specifications.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.Investigation conclusion: based on evaluation of the customer and retain samples, the customer¿s indicated failure mode for clotting with the incident lot was not observed as all samples met the required specifications.Root cause description: based on the investigation, a root cause could not be determined.The product was found to be in conformance and meet release specifications.Rationale: complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.The bd business team regularly reviews the collected data for identification of emerging trends.

• Brand Name: SEE H.10
• 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: 8595292
• Report Number: 1917413-2019-01449
• Device Sequence Number: 2192918
• Product Code: JKA
• UDI-Device Identifier: 50382903679251
• UDI-Public: 50382903679251
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K945952
• 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
• Report Date (Section B): 05/31/2019

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: 11/30/2019
• Device Catalogue Number: 367925
• Device Lot Number: 8156799
• Initial Date Received by Manufacturer: 04/23/2019
• Supplement Date Received by Manufacturer: 04/23/2019
• Initial Report FDA Received Date: 05/09/2019
• Supplement Report FDA Received Date: 05/31/2019
• 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