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

Catalog Number 762165

Device Problem Break (1069)

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

Event Date 10/01/2016

Event Type  malfunction  

Manufacturer Narrative

Results: bd received 2 relative samples from the customer facility for investigation from the same incident lot #.The samples were evaluated by simulated draw and centrifugation.The customers' indicated failure mode of centrifugation causing tube breaks with the incident lot was not observed.For level ¿a¿ complaint, no dhr review is required.Conclusion: unconfirmed complaint.Bd was unable to duplicate or confirm the customers¿ indicated failure mode because the defect was not evident in the testing of the returned samples.

Event Description

It was reported that some of the paxgene® blood rna pet tubes, (16x100 mm / 2.5ml) , with the trans red bd hemogard¿ are breaking during centrifugation.No serious injury, blood to mucous membrane exposure or medical intervention was reported.

Manufacturer Narrative

Additional information: complaint reference number: (b)(4).Customer return sample / photo and/or retain evaluation summary: 2 tubes were returned by the customer in support of this complaint.Dhr/bhr review: no qns or other issues relating to the reported defect were identified in the dhr.Investigation conclusion: the 2 returned samples were drawn with horse blood using a bd suh and msn.They were mixed, and stood in a rack for two hours, before being centrifuged at 3000rpm for 15 minutes.Neither tube cracked or broke during centrifugation.Unconfirmed.Bd was unable to duplicate or confirm the customer¿s indicated failure mode because the defect was not evident in the testing of the returned sample.Root cause description: based on an evaluation of severity and frequency it was determined that no corrective action is required at this time.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for monitoring of current trends.

• Brand Name: PAXGENE® BLOOD RNA PET TUBE, TRANS RED BD HEMOGARD¿
• 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: 7086631
• MDR Text Key: 94811383
• Report Number: 9617032-2017-00367
• Device Sequence Number: 1
• Product Code: NTW
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K042613
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/06/2018

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: 11/30/2017
• Device Catalogue Number: 762165
• Device Lot Number: 6103985
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/01/2016
• Initial Date FDA Received: 12/06/2017
• Supplement Dates Manufacturer Received: 11/01/2016
• Supplement Dates FDA Received: 03/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/12/2016
• 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