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

Catalog Number 367344

Device Problems Leak/Splash (1354); Connection Problem (2900); Material Integrity Problem (2978)

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

Event Date 08/11/2016

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Results: (b)(4) customer samples from batch 6138649, were tested under pressurized conditions for leakage.There were no defects identified.Conclusions: refer to capa (b)(4) which 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 while using the bd vacutainer® winged safety pbbcs with 12 in.Tubing 21 g x.75 in there was blood leakage from the tubing at the connection site to the vaccutainer holder.The tubing "looks thin" near the connector.No mucous membrane exposure reported.

• Brand Name: BD VACUTAINER® WINGED SAFETY PBBCS WITH 12 IN. TUBING
• 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: 7067490
• MDR Text Key: 93854379
• Report Number: 1024879-2017-00862
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903673440
• UDI-Public: 50382903673440
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K030573
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 367344
• Device Lot Number: 6138649
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/11/2016
• Initial Date FDA Received: 11/29/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/17/2016
• 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