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 Problems Leak/Splash (1354); Detachment of Device or Device Component (2907)

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

Event Date 10/31/2022

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: our quality engineer inspected the 1 photo submitted for evaluation.The reported issue of adapter / connector defective / damaged was not confirmed upon inspection of the photo.The photo provided did not show an active defect.Bd cannot confirm the cause of the failure to our manufacturing process since no sample was returned for evaluation.Examination of the actual product involved may provide clarification as to the cause of the reported failure.It is recommended that prior to the use of bd products to review the instructions for use documentation supplied to ensure the greatest chances of there being no failures during use.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.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.

Event Description

It was reported that the bd connecta¿ multiflo¿ 3-way multiple infusion manifold experienced a detached cap.The following information was provided by the initial reporter: lid falls off and becomes unsterile.The lid on the right always falls off during use.This means that a new three-way stopcock always has to be used because the other one is no longer sterile.

Event Description

It was reported that the bd connecta¿ multiflo¿ 3-way multiple infusion manifold experienced a detached cap.The following information was provided by the initial reporter: lid falls off and becomes unsterile.The lid on the right always falls off during use.This means that a new three-way stopcock always has to be used because the other one is no longer sterile.

Manufacturer Narrative

Correction: h6: imdrf annex a grid: a0501.

• 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: 15851427
• MDR Text Key: 307791060
• Report Number: 9610847-2022-00443
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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,Followup
• Report Date: 12/01/2022

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: 2126309
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/31/2022
• Initial Date FDA Received: 11/23/2022
• Supplement Dates Manufacturer Received: 12/01/2022
• Supplement Dates FDA Received: 12/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/27/2022
• 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