MAUDE Adverse Event Report: BECTON, DICKINSON & CO., (BD) 23 G X .75 IN. BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET

Catalog Number 367342

Device Problems Fail-Safe Design Failure (1222); Device Operates Differently Than Expected (2913)

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

Event Date 02/22/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Results: a sample was not returned for evaluation.A review of the device history record revealed no irregularities during the manufacture of the reported lot # 5257535.Conclusion: without a sample, an absolute root cause for this incident cannot be determined as bd was not able to duplicate or confirm the customer¿s indicated failure mode.

Event Description

It was reported that after using the 23 g x.75 in.Bd vacutainer® push button blood collection set the safety mechanism was not activated and the needle remained exposed; repeated pushing of the safety mechanism button did activate the safety mechanism.

• Brand Name: 23 G X .75 IN. 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 & CO., (BD); 1575 airport road; sumter SC 29153
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 6998474
• MDR Text Key: 92172933
• Report Number: 1024879-2017-00498
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 00382903673421
• UDI-Public: 00382903673421
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Report Date: 10/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/30/2017
• Device Catalogue Number: 367342
• Device Lot Number: 5257535
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2015
• 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