MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD CONNECTA¿ STOPCOCK

Catalog Number 394605

Device Problem Leak/Splash (1354)

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

Event Date 09/07/2022

Event Type  malfunction  

Event Description

It was reported that the bd connecta¿ stopcock leaked during use.The following information was provided by the initial reporter, translated from chinese: "(b)(6) 2022, the medical staff performed venipuncture and catheterization on the patient, and found that there was low fluid on the ground after catheterization.The inspection found that it was the leakage of the connecta, and the patient immediately explained to the patient that there was no impact on the patient, and the patient expressed understanding, and immediately replaced the infusion set and the connecta connection, and checked again for no leakage.".

Manufacturer Narrative

Initial reporter phone#: 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.

Manufacturer Narrative

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.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¿ stopcock leaked during use.The following information was provided by the initial reporter, translated from chinese: "2022.9.7, the medical staff performed venipuncture and catheterization on the patient, and found that there was low fluid on the ground after catheterization.The inspection found that it was the leakage of the connecta, and the patient immediately explained to the patient that there was no impact on the patient, and the patient expressed understanding, and immediately replaced the infusion set and the connecta connection, and checked again for no leakage.".

• Brand Name: BD CONNECTA¿ STOPCOCK
• 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: 15585338
• MDR Text Key: 301557588
• Report Number: 9610847-2022-00396
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00382903946051
• UDI-Public: (01)00382903946051
• 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: 10/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 394605
• Device Lot Number: 1182315
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/30/2021
• 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