MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. CONNECTA PLUS3 WHITE PEGS; STOPCOCK

Catalog Number 394601

Device Problems Leak/Splash (1354); Physical Resistance/Sticking (4012)

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

Event Date 03/22/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.(b)(6).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 leakage occurred with a connecta plus3 white pegs.The following information as provided by the initial reporter, "resistance when connecting the tap.Leakage during when starting the infusion: unevenness of the plastic at the lock, update on march 28, 2019: risk of bleeding to an anemic child, transfused the day before - risk of infection - risk about the treatment that could be diffused in the bed.".

Event Description

It was reported that leakage occurred with a connecta plus3 white pegs.The following information as provided by the initial reporter, "resistance when connecting the tap.Leakage during when starting the infusion: unevenness of the plastic at the lock, update om (b)(6) 2019 : risk of bleeding to an anemic child, transufsed the day before - risk of infection - risk about the treatment that could be diffused in the bed.".

Manufacturer Narrative

Investigation: bd was unable to verify the reported issues due to the provided picture did not have clear resolution.No objective evidence of this incident was found during the device history record and quality notifications analysis for the claimed lot.Based on investigation results to date, root cause for manufacturing process cannot be determined.

• Brand Name: CONNECTA PLUS3 WHITE PEGS
• Type of Device: STOPCOCK
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales
• MDR Report Key: 8496554
• MDR Text Key: 143965056
• Report Number: 9610847-2019-00283
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00382903946013
• UDI-Public: 382903946013
• 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,other,user facility
• Type of Report: Initial,Followup
• Report Date: 05/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 06/30/2021
• Device Catalogue Number: 394601
• Device Lot Number: 8185709
• Date Manufacturer Received: 03/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other