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 Disconnection (1171)

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

Event Date 08/25/2022

Event Type  malfunction  

Event Description

It was reported that the bd connecta¿ multiflo¿ 3-way multiple infusion manifold tubing separated from the catheter adapter before the operation.The following information was provided by the initial reporter, translated from chinese: "at 9 a.M.On (b)(6) 2022, a medical staff in icu used the connecta for infusion.Before the operation, it was found that the connecta was not connected properly with the deep vein catheter, and the connecta was broken by clamping the deep vein end with a vascular clamp.In subsequent clinical practice, patients were replaced with other batches of connecta for transfusion, and it was found that they were well matched with deep venous catheters without similar problems.".

Manufacturer Narrative

Initial reporter e-mail: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

H6: investigation summary: since no photos or samples displaying the reported condition of adapter / connector defective / damaged were available for examination, we were unable to fully investigate this incident.The device history records (dhr) review was performed for the lot number material identified in this complaint.According to the documented records, the product was manufactured according to the approved manufacturing procedures, specifications, and then released by quality assurance.

Event Description

It was reported that the bd connecta¿ multiflo¿ 3-way multiple infusion manifold tubing separated from the catheter adapter before the operation.The following information was provided by the initial reporter, translated from chinese: "at 9 a.M.On august 25, 2022, a medical staff in icu used the connecta for infusion.Before the operation, it was found that the connecta was not connected properly with the deep vein catheter, and the connecta was broken by clamping the deep vein end with a vascular clamp.In subsequent clinical practice, patients were replaced with other batches of connecta for transfusion, and it was found that they were well matched with deep venous catheters without similar problems.".

• 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: 15541322
• MDR Text Key: 306508777
• Report Number: 9610847-2022-00380
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00382903946013
• UDI-Public: (01)00382903946013
• 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,Followup
• Report Date: 10/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2024
• Device Catalogue Number: 394601
• Device Lot Number: 1123685
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/21/2021
• 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