MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY (BD) BD VACUTAINER® SST¿ II ADVANCE TUBES; BLOOD COLLECTION TUBE

Catalog Number 367955

Device Problems Break (1069); Detachment Of Device Component (1104)

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

Event Date 03/10/2017

Event Type  malfunction  

Manufacturer Narrative

Samples return data is unknown.The date received by manufacturer has been used for this field.Results: bd received 5 photos and 100 samples from the customer facility for investigation.Based on the evaluation of the photos, bd observed that the stoppers were not assembled to the tubes.Stopper function testing was conducted on the customer samples, and all samples met the required specifications.The manufacturing records were reviewed for the incident lot and no issues were identified.Conclusion: unconfirmed, bd was unable to duplicate or confirm the customer¿s indicated failure mode with the samples provided.Stopper pull out testing on the returned tubes did not confirm the reported defect.

Event Description

It was reported that the bd vacutainer® sst¿ ii advance tubes had the stopper pop off after collection.No serious injury, no medical interventions.No mucous membrane exposure was reported.

Manufacturer Narrative

The initial mdr was submitted with an incorrect date of event.The correct date of event is (b)(6) 2017.

• Brand Name: BD VACUTAINER® SST¿ II ADVANCE TUBES
• Type of Device: BLOOD COLLECTION TUBE
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth
• Manufacturer (Section G): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 7096022
• MDR Text Key: 94871563
• Report Number: 9617032-2017-00468
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903679558
• UDI-Public: 50382903679558
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: K023331
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/25/2018

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: Other
• Device Expiration Date: 06/30/2018
• Device Catalogue Number: 367955
• Device Lot Number: 6350567
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/31/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/15/2016
• 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