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

Catalog Number 367342

Device Problem Hole In Material (1293)

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

Event Date 11/27/2016

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.Results: bd received four (4) unopened pbbcs samples, one (1) empty pbbcs package and three (3) photos from the customer facility for investigation.Based on the visual evaluation of the photos, we observed a hole in the tubing on the product.One empty previously opened package was received for evaluation along with four sealed packages containing pbbcs units.The four units were evaluated under pressurized conditions for leakage with no defects identified.The manufacturing records were reviewed for the incident lot and no issues were identified.Further investigation has identified potential root causes in the manufacturing process where the cause of the indicated failure mode (i.E., damage to tubing) could have originated.As a result, capa (b)(4) has been initiated.Conclusion: bd was unable to duplicate or confirm the customer's indicated failure mode.

Event Description

It was reported that the customer called to report a hole in the tubing of the bd vacutainer® winged safety push button blood collection set.No serious injury or medical intervention reported.

• 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: 7117020
• MDR Text Key: 95080525
• Report Number: 1024879-2017-01321
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 00382903673421
• UDI-Public: 00382903673421
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K030573
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 10/31/2018
• Device Catalogue Number: 367342
• Device Lot Number: 6287603
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/27/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/13/2016
• 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