MAUDE Adverse Event Report: BECTON, DICKINSON & CO., (BD) 21 G X .75 IN. BD VACUTAINER® PBBCS WITH 12 IN. TUBING AND HOLDER; BLOOD COLLECTOR

Catalog Number 368652

Device Problems Fail-Safe Design Failure (1222); Device Damaged Prior to Use (2284); Difficult to Open or Remove Packaging Material (2922)

Patient Problem Needle Stick/Puncture (2462)

Event Date 03/16/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Results: a sample or photo was not returned to bd for evaluation.A review of the device history record revealed no irregularities during the manufacture of the reported lot # 5309673.Conclusion: unconfirmed complaint.Without a 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.

Event Description

It was reported that the protector safety shield was off, prior to use, from a 21 g x.75 in.Bd vacutainer® push button blood collection set with 12 in.Tubing and pre-attached holder.User got a clean needle stick injury while opening package.No serious injury, blood to mucous membrane exposure or medical intervention was reported.

• Brand Name: 21 G X .75 IN. BD VACUTAINER® PBBCS WITH 12 IN. TUBING AND HOLDER
• Type of Device: BLOOD COLLECTOR
• 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: 7080848
• MDR Text Key: 93884794
• Report Number: 1024879-2017-00274
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 00382903686520
• UDI-Public: 00382903686520
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K980414
• 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: 11/01/2017

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: 10/31/2017
• Device Catalogue Number: 368652
• Device Lot Number: 5309673
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/17/2016
• 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