MAUDE Adverse Event Report: BECTON DICKINSON BD MICROTAINER® BLOOD COLLECTION TUBES; BLOOD COLLECTION TUBES.

Catalog Number 365974

Device Problem Occlusion Within Device (1423)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/11/2015

Event Type  malfunction  

Manufacturer Narrative

Results: bd received samples from the customer facility for investigation.The samples were evaluated and the customer's indicated failure mode for blood clotting in tubes with the incident lot was observed.Additionally, retention samples were selected for evaluation, and the customer's indicated failure mode for blood clotting in tubes was not observed.Tubes were found that did not contain additive.A review of the manufacturing records was completed for the incident lot and interventions were reported not to have affected product quality.Conclusion: the absolute root cause is indeterminate.

Event Description

It was reported that bd microtainer® blood collection tubes were clotting.No serious injury, no medical intervention.

• Brand Name: BD MICROTAINER® BLOOD COLLECTION TUBES
• Type of Device: BLOOD COLLECTION TUBES.
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 7096773
• MDR Text Key: 94850107
• Report Number: 2243072-2017-00336
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 00382903659746
• UDI-Public: 00382903659746
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K991702
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 06/30/2016
• Device Catalogue Number: 365974
• Device Lot Number: 5027818
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/16/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/27/2015
• 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