MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY (BD) PAXGENE® BLOOD RNA TUBE; BLOOD COLLECTION TUBE

Catalog Number 762165

Device Problem Crack (1135)

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

Event Date 05/24/2017

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 cracked shield of stopper with the incident lot was observed.A review of the manufacturing records was completed for the incident lot and no issues were identified.Conclusion - based on an evaluation of severity and frequency, it was determined that no corrective action is not required at this time.Complaints received for this device and reported condition will continue to be tracked and trended.

Event Description

It was reported that paxgene® blood rna tube had a cracked tube.No injury or medical intervention reported.

• Brand Name: PAXGENE® BLOOD RNA TUBE
• 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: 7084776
• MDR Text Key: 94411913
• Report Number: 9617032-2017-00500
• Device Sequence Number: 1
• Product Code: NTW
• UDI-Device Identifier: 54053727621653
• UDI-Public: 54053727621653
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: K042613
• 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: 11/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2017
• 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: 762165
• Device Lot Number: 6316738
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/11/2016
• 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