MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD VACUTAINER® WINGED SAFETY PUSH BUTTON BLOOD COLLECTION SET

Catalog Number 367324

Device Problem Split (2537)

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

Event Date 10/05/2015

Event Type  malfunction  

Manufacturer Narrative

Bd received samples, representative and actual, from the customer facility for investigation.The samples were evaluated and the customer's indicated failure mode for device breakage with the actual sample was observed.The indicated failure mode for the representative samples was not observed.An absolute root cause for this incident cannot be determined as bd was not able to duplicate the customer¿s indicated failure mode.Complaints received for this device and reported condition will continue to be tracked and trended.

Event Description

It was reported that a push button from a 23 g x.75 in.Bd vacutainer® winged safety push button blood collection set, split in two upon use.There was no report of injury or medical intervention.

• Brand Name: BD VACUTAINER® WINGED SAFETY PUSH BUTTON BLOOD COLLECTION SET
• 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: 7071873
• MDR Text Key: 94203342
• Report Number: 1710034-2017-00353
• 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
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 11/02/2017

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: Other
• Device Expiration Date: 07/31/2017
• Device Catalogue Number: 367324
• Device Lot Number: 5177675
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/12/2015
• Initial Date FDA Received: 11/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/26/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other