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

Catalog Number 397251

Device Problem Leak/Splash (1354)

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

Event Date 10/16/2018

Event Type  malfunction  

Manufacturer Narrative

Device expiration date: unknown.Device manufacture date: unknown.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 in connection with the t-port was leaking.There was no report of exposure, serious injury, or medical intervention.

Event Description

It was reported that a bd connecta extension tube in connection with the t-port was leaking.There was no report of exposure, serious injury, or medical intervention.

Manufacturer Narrative

Since a lot number could not be connected to the device identified in the complaint, bd investigators could not conduct a device history review for this event.Additionally, a sample has not been submitted for evaluation and testing, preventing bd engineers from conducting a full investigation and determining a root cause of the failure mode identified in your description of the event.We could not determine the root cause and cannot confirm the issue stated by the customer due that no samples were sent for evaluation or lot number provided to perform a dhr review.

• 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: 8030347
• MDR Text Key: 125957127
• Report Number: 9610847-2018-00364
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00382903972517
• UDI-Public: 382903972517
• 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: distributor,other
• Type of Report: Initial,Followup
• Report Date: 11/14/2018

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: Lay User/Patient
• Device Catalogue Number: 397251
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: 10/17/2018
• Initial Date FDA Received: 11/01/2018
• Supplement Dates Manufacturer Received: 10/17/2018
• Supplement Dates FDA Received: 11/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other