MAUDE Adverse Event Report: BECTON, DICKINSON & CO., (BD) BD VACUTAINER® WINGED SAFETY PBBCS WITH 12 IN. TUBING 21 G X .75 IN; BLOOD COLLECTION SET

Catalog Number 367344

Device Problem Misassembled (1398)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/23/2015

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone #: (b)(6).Visual inspection of the returned sample and returned photos confirmed the complaint.As there are vision systems in place, this unit may have been rejected and inadvertently placed back on the line.A review of the device history record revealed no irregularities during the manufacture of the reported lot # 5176866.Conclusion: an absolute root cause for this incident cannot be determined.

Event Description

It was reported that the bd vacutainer® winged safety pbbcs with 12 in.Tubing 21 g x.75 in was assembled improperly.One customer sample was received loose in the package with the wing in a backward position.No injury or medical intervention.

• Brand Name: BD VACUTAINER® WINGED SAFETY PBBCS WITH 12 IN. TUBING 21 G X .75 IN
• 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: 6999528
• MDR Text Key: 92074655
• Report Number: 1024879-2017-00227
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903673440
• UDI-Public: 50382903673440
• 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: 10/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 06/30/2017
• Device Catalogue Number: 367344
• Device Lot Number: 5176866
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/25/2015
• 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