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

Catalog Number 367957

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 03/31/2017

Event Type  malfunction  

Manufacturer Narrative

Results: bd received samples and photos from the customer facility for investigation.The samples and photos were evaluated and the customer¿s indicated failure mode for additive abnormality and the incorrect additive quantity with the incident lot was observed.Additionally, a review of the device history records was completed for the incident lot and no issues were identified.Conclusion: confirmed.The root cause for the additive abnormality and the incorrect additive quantity was determined to be from the additive spray nozzle become slightly occluded, delivering varying levels of additive into the tubes, until it final becomes blocked.

Event Description

It was reported that customer found 80 bd vacutainer® brand sst ii advance tubes without additive.Also customer found 20 bd vacutainer® brand sst ii advance tubes in which additive was not symmetrical on the tube walls.No serious injury or medical intervention reported.

• Brand Name: BD VACUTAINER® BRAND 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: 7100783
• MDR Text Key: 94947186
• Report Number: 9617032-2017-00549
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 00382903679577
• UDI-Public: 00382903679577
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K023331
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/22/2017

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
• Device Operator: Other
• Device Expiration Date: 04/13/2017
• Device Catalogue Number: 367957
• Device Lot Number: 6113594
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/31/2017
• Initial Date FDA Received: 12/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/22/2016
• 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