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

Catalog Number 368652

Device Problems Decrease in Suction (1146); Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/05/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Sixteen customer samples were submerged leak tested.There were no defects identified.However, attached photos show blood leakage in the iv area of the needle/tubing.A review of the device history record was completed.All inspections were in compliance with requirements.Based on the investigation results, no root cause from the manufacturing process was identified as a contributor to the reported failure.

Event Description

It was reported that 21 g x.75 in.Bd vacutainer® pbbcs with 12 in.Tubing and pre-attached holder leaked from the junction between the iv cannula and tubing causing blood to accumulate in the safety shield.This sometimes causes the vacuum to be lost.No injury or medical intervention reported.

• Brand Name: 21 G X .75 IN. BD VACUTAINER® PBBCS WITH 12 IN. TUBING AND 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: 7058856
• MDR Text Key: 93728308
• Report Number: 1024879-2017-01086
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903686525
• UDI-Public: 50382903686525
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K980414
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/31/2019
• Device Catalogue Number: 368652
• Device Lot Number: 7016943
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/03/2017
• 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