MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD VACUTAINER® WINGED SAFETY PBBCS WITH TUBING; BLOOD COLLECTION SET

Catalog Number 367344

Device Problems Fluid/Blood Leak (1250); Material Separation (1562)

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

Event Date 12/06/2017

Event Type  malfunction  

Manufacturer Narrative

No lot # provided.Medical device expiration date: unknown.Device manufacture date: unknown.A sample is not available for evaluation.However, a no sample investigation and device history record review of potential lot numbers will be completed.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that when using a bd vacutainer® winged safety pbbcs with tubing the barrel separated and blood leaked onto the healthcare workers ppe and the patient¿s skin and bed.There was no report of exposure to mucous membranes, injury or medical interventions.

Manufacturer Narrative

Additional information:  four potential lot numbers were provided for the previously reported incident.The information for each lot number is as follows: medical device lot #: 7030628, medical device expiration date: 2/28/2019, device manufacture date: 1/30/2017.Medical device lot #: 7030619, medical device expiration date: 2/28/2019, device manufacture date: 1/30/2017.Medical device lot #: 7030592, medical device expiration date: 2/28/2019, device manufacture date: 1/30/2017.  medical device lot #: 7013816, medical device expiration date: 1/31/2019, device manufacture date: 1/13/2017.Investigation summary: bd had not received samples or photos from the customer facility for evaluation; therefore, the investigation was limited.Additionally, the lot number involved in this incident could not be confirmed by the customer; therefore, all potential lot numbers indicated by the customer were investigated.A review of the device history records was completed for each potential lot number and, based on this review, all product specifications and requirements for lot release were met; there were no related quality non-conformances during manufacturing of the product.Investigation conclusion: as no samples or photos were received for evaluation, the customer's indicated failure mode was not observed by bd.Root cause description: as there was no sample or photo available for evaluation, a root cause could not be determined.

• Brand Name: BD VACUTAINER® WINGED SAFETY PBBCS WITH TUBING
• Type of Device: BLOOD COLLECTION SET
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer (Section G): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 7152733
• MDR Text Key: 96116186
• Report Number: 1710034-2017-00488
• 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: health professional,other,use
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Phlebotomist
• Device Catalogue Number: 367344
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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