MAUDE Adverse Event Report: BECTON, DICKINSON & CO., (BD) BD VACUTAINER® PLUS PLASTIC SST TUBE; BLOOD COLLECTION TUBE

Catalog Number 367983

Device Problem Detachment Of Device Component (1104)

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

Event Date 04/06/2016

Event Type  malfunction  

Manufacturer Narrative

Results: bd had not received samples or photos from the customer facility for evaluation; therefore, the investigation was limited.Retention samples were selected from bd inventory for evaluation, and the customer's indicated failure mode for faulty tube stoppers was not observed as all samples met specifications.A review of the manufacturing records was completed for the incident lot and no issues were identified.Conclusion: bd was unable to duplicate or confirm the customer's mode of failure.

Event Description

It was reported that some tube stoppers were coming off of the bd vacutainer® plus plastic sst tubes.No serious injury or medical intervention.

• Brand Name: BD VACUTAINER® PLUS PLASTIC SST TUBE
• Type of Device: BLOOD COLLECTION TUBE
• Manufacturer (Section D): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• Manufacturer (Section G): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 7088185
• MDR Text Key: 94805042
• Report Number: 1024879-2017-01199
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 00382903679836
• UDI-Public: 00382903679836
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K023075
• 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: 11/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 367983
• Device Lot Number: 5356537
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/22/2015
• 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