MAUDE Adverse Event Report: BECTON, DICKINSON & CO., (BD) BD VACUTAINER® WINGED SAFETY PBBCS WITH 12 IN TUBING AND ADAPTER; BLOOD COLLECTION SET

Catalog Number 367342

Device Problem Device Slipped (1584)

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

Event Date 11/14/2017

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that while a lab assistant was performing a blood draw using a bd vacutainer® winged safety push button blood collection set with 12 in tubing and luer adapter, it was reported the needle¿s protective rubber sheath completely pulled out of the device when inserting into the connecting tube.There was no report of injury or medical intervention.

Manufacturer Narrative

Investigation summary: bd had not received samples, but photos were provided by the customer facility for investigation.The photos were evaluated and separation of the np (non-patient) needle was observed.Additionally, retention samples were selected from bd inventory for testing and upon completion, the customer's indicated failure mode for separation of the np needle was not observed as all retention samples met required specifications.A review of the device history record was completed for the incident lot 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: based on evaluation of the customer photos, the customer¿s indicated failure mode for separation of the np needle with the incident lot was observed.Additionally, testing of the retain samples was conducted and separation of the np needle was not observed.Root cause description: based on the investigation, a root cause could not be determined.

• Brand Name: BD VACUTAINER® WINGED SAFETY PBBCS WITH 12 IN TUBING AND ADAPTER
• Type of Device: BLOOD COLLECTION SET
• Manufacturer (Section D): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• Manufacturer (Section G): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 7097927
• MDR Text Key: 94799104
• Report Number: 1024879-2017-01226
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903673426
• UDI-Public: 50382903673426
• 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,Followup
• Report Date: 01/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2019
• Device Catalogue Number: 367342
• Device Lot Number: 7242825
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/30/2017
• 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