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 Loose or Intermittent Connection (1371)

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

Event Date 09/28/2022

Event Type  malfunction  

Event Description

It was reported that the bd connecta¿ multiflo¿ 3-way multiple infusion manifold had a loose connection while pumping fluids.The following information was provided by the initial reporter, translated from "(b)(6) 2022 quasi - general anesthesia downlink ventricle peritoneal drainage, due to the need of general anesthesia, pick connecta conversion head for pumping fluids, found that small intravenous line of discontinuity in the air, thinking is the connecta connection is not tight, tight after processing, still no improvement, in order to avoid air enters the body, immediately to replace another one connection pipe, no adverse consequences were caused due to timely discovery.".

Manufacturer Narrative

Medical device expiration date: unknown.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.Device manufacture date: unknown.

Manufacturer Narrative

H6: investigation summary bd was unable to perform a thorough investigation as no sample, lot, or batch number were provided.A device history review could not be completed as no batch number was provided.

Event Description

It was reported that the bd connecta¿ multiflo¿ 3-way multiple infusion manifold had a loose connection while pumping fluids.The following information was provided by the initial reporter, translated from "(b)(6)2022 quasi - general anesthesia downlink ventricle peritoneal drainage, due to the need of general anesthesia, pick connecta conversion head for pumping fluids, found that small intravenous line of discontinuity in the air, thinking is the connecta connection is not tight, tight after processing, still no improvement, in order to avoid air enters the body, immediately to replace another one connection pipe, no adverse consequences were caused due to timely discovery.".

• 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: 15756958
• MDR Text Key: 307818903
• Report Number: 9610847-2022-00424
• 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: 11/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 394601
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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