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

Catalog Number 367324

Device Problem Device Inoperable (1663)

Patient Problem Needle Stick/Puncture (2462)

Event Date 11/05/2015

Event Type  Injury  

Manufacturer Narrative

Results: bd received samples from the customer facility for investigation.The samples were functionally tested, visually evaluated and the customer's indicated failure mode for the needle not covered by the safety with the incident lot was not observed as all samples tested within specifications a review of the manufacturing records was completed for the incident lot and no issues were identified.Conclusion: based on the investigation results, no root cause from the manufacturing process was identified as a contributor to the reported failure.

Event Description

It was reported that the bd vacutainer® push button blood collection set malfunctioned and allowed the needle to advance outside the safety compartment on a used device, resulting in a dirty needle stick injury.Medical interventions are unknown.

• Brand Name: BD VACUTAINER® 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 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: 7116932
• MDR Text Key: 94821510
• Report Number: 1710034-2017-00343
• Device Sequence Number: 1
• Product Code: JKA
• 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: 12/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 06/30/2017
• Device Catalogue Number: 367324
• Device Lot Number: 5160975
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/05/2016
• Initial Date FDA Received: 12/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/09/2015
• 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