MAUDE Adverse Event Report: BECTON, DICKINSON & CO., (BD) BD VACUTAINER® WINGED SAFETY PUSH BUTTON BLOOD COLLECTION SET

Catalog Number 367342

Device Problem Fail-Safe Design Failure (1222)

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

Event Date 04/18/2016

Event Type  malfunction  

Manufacturer Narrative

Results: bd had not received samples or photos from the customer facility for evaluation.No dhr was performed.The complaint was previously confirmed though samples received from crs complaint (b)(4).Capa (b)(4) was initiated to document the root cause.Conclusion: the root cause is misaligned front and rear barrels leading to damaged parts allowing for the barrels to become separated upon activation.Refer to capa (b)(4) for complete documentation and action plans.

Event Description

It was reported that bd vacutainer® winged safety push button blood collection set had a safety failure.No injury or medical intervention.

• Brand Name: BD VACUTAINER® WINGED SAFETY PUSH BUTTON BLOOD COLLECTION SET
• Type of Device: BLOOD COLLECTION SET
• Manufacturer (Section D): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• Manufacturer (Section G): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 7114892
• MDR Text Key: 95189154
• Report Number: 1024879-2017-01307
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 00382903673421
• UDI-Public: 00382903673421
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K030573
• 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: 12/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2017
• 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: 367342
• Device Lot Number: 5355533
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/18/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/21/2015
• 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