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

Catalog Number 367338

Device Problems Bent (1059); Fluid/Blood Leak (1250)

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

Event Date 05/04/2016

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Results: a sample was not returned for evaluation.Two customer photographs were returned and showed blood leakage at the rubber sleeve.The photographs also showed the stopper needle bent.A review of the device history record revealed no irregularities during the manufacture of the reported lot #5309921.Conclusion: without a sample, an absolute root cause for this incident can be determined as bd was able to duplicate or confirm the customer¿s indicated failure mode.

Event Description

It was reported that a 21 g x.75 in bd vacutainer® winged safety push button blood collection set had leakage at the rubber sleeve and the stopper needle was found bent.There was no serious injury or medical intervention reported.

• Brand Name: BD VACUTAINER® WINGED SAFETY 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 & CO., (BD); 1575 airport road; sumter SC 29153
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 7071820
• MDR Text Key: 93844469
• Report Number: 1024879-2017-00765
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 00382903673384
• UDI-Public: 00382903673384
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K030573
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 10/31/2017
• Device Catalogue Number: 367338
• Device Lot Number: 539921
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/04/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/05/2015
• 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