MAUDE Adverse Event Report: BECTON, DICKINSON & CO. BD VACUTAINER® GLASS PLASMA TUBE. LT. BLUE BD HEMOGARD¿ CLOSURE; BLOOD COLLECTION TUBE

Catalog Number 369714

Device Problem Burst Container or Vessel (1074)

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

Event Date 01/06/2017

Event Type  malfunction  

Manufacturer Narrative

A sample was not available for evaluation.However, a no sample investigation and device history record review was completed.There were no related quality notifications.All process and final inspections complied with specification requirements.Conclusion: this defect is under investigation through capa reference number: (b)(4) and fa number: (b)(4).An (b)(4) project was initiated and is underway.This complaint was confirmed based on a known issue.(b)(4).

Event Description

It was reported that the top of a bd vacutainer® glass plasma tube.Lt.Blue bd hemogard¿ closure tube exploded in the staff member¿s hand.In addition, it was also reported that this was the (b)(4) occurrence of this issue with lot number 6173983.The lot number was removed from the lab at fmc.There was no report of injury or medical intervention.

• Brand Name: BD VACUTAINER® GLASS PLASMA TUBE. LT. BLUE BD HEMOGARD¿ CLOSURE
• Type of Device: BLOOD COLLECTION TUBE
• Manufacturer (Section D): BECTON, DICKINSON & CO.; 150 south 1st avenue; broken bow NE 68822
• Manufacturer (Section G): BECTON, DICKINSON & CO.; 150 south 1st avenue; broken bow NE 68822
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 6753118
• MDR Text Key: 81599966
• Report Number: 1917413-2017-00051
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K091292
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/26/2017

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: 12/31/2017
• Device Catalogue Number: 369714
• Device Lot Number: 6173983
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/09/2017
• Initial Date FDA Received: 07/30/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/21/2016
• 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