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

Catalog Number 368656

Device Problems Break (1069); Detachment Of Device Component (1104)

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

Event Date 03/08/2016

Event Type  malfunction  

Manufacturer Narrative

Bd had not received samples, but a photo was provided by the customer facility, and it showed the customers' indicated failure mode of a broken hub.A review of the device history record was completed for incident lot# 5105892 and all inspections were in compliance with requirements.Refer to capa (b)(4).Unconfirmed complaint.Without any sample, an absolute root cause for this incident cannot be determined as bd was not able to duplicate or confirm the customers¿ indicated failure mode.Refer to capa (b)(4).

Event Description

It was reported that when the activation button of the bd vacutainer® push button blood collection set with pre-attached holder was used, it broke and fell apart.No serious injury, blood to mucous membrane exposure or medical intervention was reported.

• Brand Name: BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER
• 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: 7080539
• MDR Text Key: 94266275
• Report Number: 1024879-2017-00254
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 00382903686568
• UDI-Public: 00382903686568
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K011984
• 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: 10/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 04/30/2017
• Device Catalogue Number: 368656
• Device Lot Number: 5105892
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/15/2015
• 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