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

Catalog Number 368968

Device Problems Sticking (1597); Loss of Data (2903)

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

Event Date 03/07/2016

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.Results: a sample was not returned for evaluation.The retention samples did not have the reported defect.The shrink wrap on the two retained shelf-packs was not adhering to the tubes it surrounds.A review of the device history record revealed no irregularities during the manufacture of the reported lot # 6006611.Conclusion: without a sample, an absolute root cause for this incident cannot be determined as bd was not able to duplicate or confirm the customer¿s indicated failure mode.

Event Description

It was reported that bd vacutainer® sst¿ tubes had the rack plastic film stuck to the first line of tubes.When it was removed the tube labels were removed too causing information to be lost.No injury or medical intervention reported.

• Brand Name: BD VACUTAINER® SST¿ TUBES
• Type of Device: BLOOD COLLECTION TUBES
• 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: 7073104
• MDR Text Key: 94206508
• Report Number: 9617032-2017-00314
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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
• Report Date: 11/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 06/30/2017
• Device Catalogue Number: 368968
• Device Lot Number: 6006611
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/06/2016
• 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