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

Catalog Number 367374

Device Problems Air Leak (1008); Gel Leak (1267)

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

Event Date 05/23/2017

Event Type  malfunction  

Manufacturer Narrative

Results: evaluation of the attached photographs shows several tubes, one with the correct amount of gel but with an air bubble in the gel, two with twice the amount of gel, and two with no gel.No similar defects were identified in the (b)(4) retained samples from this lot number.A review of the device history record revealed no irregularities during the manufacture of the reported lot #7067956.Conclusion: bd was able to confirm the customer¿s indicated failure modes with the photographs provided.The most likely root cause for the reported defect is that a tube already containing gel was used to either infill a space or replace a defective tube prior to the gel dispense process, resulting in a tube with twice the required amount of gel.The empty tubes were probably infilled by mistake after the gelling stage, whilst the bubble would have been caused by air in the dispense system.

Event Description

It was reported that bd vacutainer® pst¿ tubes had no gel, too much gel, and bubbles in the gel.No injury or medical intervention reported.

• Brand Name: BD VACUTAINER® PST¿ 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: 7098403
• MDR Text Key: 94822061
• Report Number: 9617032-2017-00597
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 11/17/2017

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: 09/30/2018
• Device Catalogue Number: 367374
• Device Lot Number: 7067956
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/23/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/08/2017
• 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