MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD CONNECTA¿ EXTENSION TUBE; EXTENSION TUBING

Catalog Number 395095

Device Problems Backflow (1064); Kinked (1339)

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

Event Date 05/30/2018

Event Type  Injury  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that a bd connecta¿ extension tube was found kinked while performing an operation which resulted in blood backflow and a delay in treatment.There was no report of exposure or medical intervention.

Event Description

It was reported that a bd connecta¿ extension tube was found kinked while performing an operation which resulted in blood backflow and a delay in treatment.There was no report of exposure or medical intervention.

Manufacturer Narrative

Investigation summary: the device history report for lot number 7304699 was reviewed, no related abnormalities were found.Material number 395095 for lot 7304699 was manufactured on 11/05/2017.According to the sampling plan applied for product performance, this lot was accepted and released, with no defects being noted during final assembly or in packaging visual inspections.Additionally a photograph was submitted for the purpose of aiding in our quality engineers investigation, the provided photograph displayed a kinked extension tube, no additional damage such as cracks as or leakage were noted during the course of our investigation.The most likely root cause for this complaint is product design.The kinked tubing is inherent to the packaging process as a direct result of the length of the component extension tubing.This issue is not associated with damage, cracks, or leakage.Investigation conclusion: based on investigation results to date, root cause is associated to the manufacturing process (inherent product condition).

• Brand Name: BD CONNECTA¿ EXTENSION TUBE
• Type of Device: EXTENSION TUBING
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales
• MDR Report Key: 7634967
• MDR Text Key: 112223478
• Report Number: 9610847-2018-00164
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 07/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/30/2020
• Device Catalogue Number: 395095
• Device Lot Number: 7304699
• Date Manufacturer Received: 05/31/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other