MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD CONNECTA¿ MULTIFLO¿ 3-WAY MULTIPLE INFUSION MANIFOLD; STOPCOCK

Catalog Number 394601

Device Problem Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/30/2022

Event Type  malfunction  

Event Description

It was reported that the bd connecta¿ multiflo¿ 3-way multiple infusion manifold leaked.The following information was provided by the initial reporter, translated from chinese to english: during the process, one of the connecta leakage was found.

Manufacturer Narrative

Initial reporter phone#: (b)(6).Investigation summary: since no photos or samples displaying the reported condition of leakage were available for examination, we were unable to fully investigate this incident.Examination of the product involved may provide clarification as to the cause for the reported failure.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.

• Brand Name: BD CONNECTA¿ MULTIFLO¿ 3-WAY MULTIPLE INFUSION MANIFOLD
• Type of Device: STOPCOCK
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• Manufacturer (Section G): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15671195
• MDR Text Key: 303167105
• Report Number: 9610847-2022-00407
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 394601
• Device Lot Number: 1335865
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/30/2022
• Initial Date FDA Received: 10/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/16/2021
• 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