MAUDE Adverse Event Report: BECTON, DICKINSON & CO., (BD) BD VACUTAINER® WINGED SAFETY PBBCS WITH TUBING; BLOOD COLLECTION SET

Catalog Number 367344

Device Problems Fluid/Blood Leak (1250); Hole In Material (1293)

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

Event Date 03/28/2017

Event Type  malfunction  

Manufacturer Narrative

Bd had not received samples or photos from the customer facility for evaluation; therefore, the investigation was limited.A review of the manufacturing records was completed for the incident lot and no issues were identified.Bd was unable to confirm the customer's indicated failure mode.

Event Description

It was reported that the clinician experienced blood leakage through holes in the tubing of the bd vacutainer® winged safety pbbcs.No serious injury or medical intervention reported.

• Brand Name: BD VACUTAINER® WINGED SAFETY PBBCS WITH TUBING
• 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: 7120957
• MDR Text Key: 95075075
• Report Number: 1024879-2017-00996
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903673440
• UDI-Public: 50382903673440
• 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: 12/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/31/2019
• Device Catalogue Number: 367344
• Device Lot Number: 7027536
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/2017
• 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