MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® SODIUM HEPARIN¿ (NH) BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number	366480
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	02/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 heparin (nh) blood collection tubes had micro clots.This occurred on 3 separate occasions.No serious injury or medical intervention was reported.The following information was provided by the initial reporter: ¿material no.366480, batch no.8099579.Email received inquiring on an complaint, stating 3 occurences of micro-clotting in nahep tube were observed.Email stated, - "hello, we recently collected blood from normal healthy donors into nahep vacutainer tubes.Within 30-60 minutes of the draw, the client picks up the tubes for their research.The tubes processed in the first 12hrs were fine, but at 24 hours 2 of the 6 tubes had some micro-clotting and at 48 hours a 3rd tube had micro-clotting.The client claims the tubes were stored at room temp on a slow rocker.Do you have any suggestions as to why micro-clotting would occur at 24 hrs and 48 hours? thank you".
Event or Problem Description
It was reported that bd vacutainer® sodium heparin (nh) blood collection tubes had micro clots.This occurred on 3 separate occasions.No serious injury or medical intervention was reported.The following information was provided by the initial reporter: ¿material no.366480, batch no.8099579.Email received inquiring on an complaint, stating 3 occurences of micro-clotting in nahep tube were observed.Email stated, - "hello, we recently collected blood from normal healthy donors into nahep vacutainer tubes.Within 30-60 minutes of the draw, the client picks up the tubes for their research.The tubes processed in the first 12hrs were fine, but at 24 hours 2 of the 6 tubes had some micro-clotting and at 48 hours a 3rd tube had micro-clotting.The client claims the tubes were stored at room temp on a slow rocker.Do you have any suggestions as to why micro-clotting would occur at 24hrs and 48hours? thank you".
Additional Manufacturer Narrative
Investigation: investigation summary: bd received samples from the customer facility for investigation.The samples were evaluated, along with retention samples selected from bd inventory and upon completion, 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.Additionally, bd technical service has conducted troubleshooting to the customer and reviewed potential root causes of microclotting.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: BD VACUTAINER® SODIUM HEPARIN¿ (NH) BLOOD 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: 8453713
• Report Number: 1917413-2019-01052
• Device Sequence Number: 2887349
• Product Code: JKA
• UDI-Device Identifier: 50382903664806
• UDI-Public: 50382903664806
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: PREAMENDMENT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2019

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: 04/30/2020
• Device Catalogue Number: 366480
• Device Lot Number: 8099579
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2019
• Initial Date Received by Manufacturer: 03/11/2019
• Supplement Date Received by Manufacturer: 03/11/2019
• Initial Report FDA Received Date: 03/26/2019
• Supplement Report FDA Received Date: 05/01/2019
• 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