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

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

Event Date 09/20/2016

Event Type  malfunction  

Manufacturer Narrative

Results: (b)(4) samples were returned for evaluation.Conclusion: this is a confirmed complaint as bd is aware of tubing leakage complaints with remediation actions being taken.No additional sample testing is required as this is a confirmed complaint.Dhr review is not required.Refer to capa (b)(4).

Event Description

It was reported that the 23 g x.75 in.Bd vacutainer® push button blood collection set was noticed to have the vacuum decreasing.Blood was then seen coming out from where the tubing enters the solid white section just before the part that attaches to collection piece.Draw was stopped and had to be recollected from a different draw point.There was no injury or medical intervention reported.

• 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: 7059987
• MDR Text Key: 93467342
• Report Number: 1024879-2017-00543
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903673426
• UDI-Public: 50382903673426
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 10/25/2017

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: 05/31/2018
• Device Catalogue Number: 367342
• Device Lot Number: 6132861
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/11/2016
• 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