MAUDE Adverse Event Report: BECTON, DICKINSON & CO., (BD) BD VACUTAINER® PUSH BUTTON SET WITH 12 IN. TUBING AND HOLDER; BLOOD COLLECTION SET

Catalog Number 368657

Device Problem Split (2537)

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

Event Date 07/07/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(6).The customer returned one reported sample.And photos.The returned customer sample and photos confirm severed tubing.As this is a confirmed complaint for this lot, a dhr review is not required confirmed complaint.Capa (b)(4) has been initiated for this issue to document the investigation path, root cause analysis and remediation plan to include corrective and preventive actions.

Event Description

It was reported that before using the 21 g x.75 in.Bd vacutainer® push button set with 12 in.Tubing and pre-attached holder the customer noticed the tubing was compressed and split in some places.No injury or medical intervention.

• Brand Name: BD VACUTAINER® PUSH BUTTON SET WITH 12 IN. TUBING AND 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: 7072692
• MDR Text Key: 93819044
• Report Number: 1024879-2017-00855
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K011984
• 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: 11/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 07/31/2017
• Device Catalogue Number: 368657
• Device Lot Number: 5205711
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/24/2015
• 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