MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY (BD) BD VACUTAINER® CRITICAL CARE SYRINGES; BLOOD COLLECTION SET

Catalog Number 364376

Device Problems Leak/Splash (1354); Defective Device (2588)

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

Event Date 05/17/2017

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 plunger defect with the incident lot was observed.A review of the manufacturing records was completed for the incident lot and no issues were identified.Conclusion - there are a number of potential root causes for this type of defect.The stopper was not correctly attached by the manufacturer.The stopper was partially removed during shipping ¿ these plungers are shipped bulk in large bags.Due to a lack of lubricant in the syringe barrel the stopper dragged on the barrel wall and was partially dislodged.

Event Description

It was reported that the bd vacutainer® critical care syringes had a plunger defect.This resulted in a leak behind the plunger.No injury or medical intervention reported.

• Brand Name: BD VACUTAINER® CRITICAL CARE SYRINGES
• Type of Device: BLOOD COLLECTION SET
• 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: 7077983
• MDR Text Key: 94207561
• Report Number: 9617032-2017-00442
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K022426
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 08/31/2018
• Device Catalogue Number: 364376
• Device Lot Number: 6232637
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/17/2017
• Initial Date FDA Received: 12/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/19/2016
• 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