MAUDE Adverse Event Report: BECTON, DICKINSON & CO. BD VACUTAINER® GLASS SERUM TUBE; BLOOD COLLECTION TUBE

Catalog Number 366430

Device Problem Occlusion Within Device (1423)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/01/2015

Event Type  malfunction  

Manufacturer Narrative

Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 4280887, medical device expiration date: 10/31/2016, device manufacture date: 10/07/2014.Medical device expiration date: 07/31/2017, device manufacture date: 6/24/2015.Results: bd received nine samples from the customer facility for investigation.The samples were functionally tested with blood and evaluated and the customer's indicated failure mode for clotting with the incident lot was not observed.Additionally, crs complaint (b)(4) did a test of retained samples from this lot.Ten retention samples were evaluated and were confirmed for poor clot formation, red cell hang-up, and red cell stopper fibrin ring.A review of the manufacturing records was completed for the incident lot and no issues were identified.Conclusion: this complaint is confirmed through retention samples by the investigation in crs complaint (b)(4).No root cause was identified.

Event Description

It was reported that the bd vacutainer® glass serum tube was clotting.This happened three times.No injury or medical intervention.

• Brand Name: BD VACUTAINER® GLASS SERUM TUBE
• Type of Device: BLOOD COLLECTION TUBE
• Manufacturer (Section D): BECTON, DICKINSON & CO.; 150 south 1st avenue; broken bow NE 68822
• Manufacturer (Section G): BECTON, DICKINSON & CO.; 150 south 1st avenue; broken bow NE 68822
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 7099549
• MDR Text Key: 94382524
• Report Number: 1917413-2017-00386
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PREAMENDMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 10/31/2016
• Device Catalogue Number: 366430
• Device Lot Number: 4280887
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/01/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Outcome(s): Other