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

Catalog Number 367336

Device Problems Leak/Splash (1354); Split (2537)

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

Event Date 07/08/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Ten customer returned samples were tested under pressurized conditions for leakage in tubing.A photo was sent that shows a hole in the tubing.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.Capa (b)(4) was opened for this device.

Event Description

It was reported that 23 g x.75 in.Bd vacutainer® push button blood collection set with 7 in.Tubing and luer adapter leaked blood from a split in the tubing during collection of a blood sample.No mucous membrane exposure.The nurse used appropriate safety equipment during the collection.No serious injury and no medical intervention required.

• 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: 7060238
• MDR Text Key: 93301927
• Report Number: 1024879-2017-00458
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 00382903673360
• UDI-Public: 00382903673360
• Combination Product (y/n): N
• Reporter Country Code: CI
• 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: 10/23/2017

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: Nurse
• Device Expiration Date: 07/31/2017
• Device Catalogue Number: 367336
• Device Lot Number: 5215770
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/11/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/03/2015
• 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