MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD CONNECTA PLUS3 BLUE; INTRAVASCULAR ADMINISTRATION SET

Catalog Number 394602

Device Problem Leak/Splash (1354)

Patient Problem Insufficient Information (4580)

Event Date 10/10/2023

Event Type  malfunction  

Manufacturer Narrative

B3.The date received by manufacturer has been used for this field.H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported bd connecta plus3 blue leaked.The following information was provided by the initial reporter; "our distributor in bulgaria - rsr received a complaint from the national hospital regarding the leakage from bd connecta¿ plus 3 360° blue (o4602-9), art.No.394602, according to the delivered quantities by us with the following lot numbers: 3012416/ 31.01.2026; 3058487/ 31.01.2026; 3032920/ 31.01.2026 based on the signed new tender contract with the hospital.Please be aware that complaints have been received from several departments after the replacement of b.Braun¿s stopcocks according to the previous tender contract.".

Event Description

No additional information was provided our distributor in bulgaria - rsr received a complaint from the national hospital regarding the leakage from bd connecta¿ plus 3 360° blue (o4602-9), art.No.394602, according to the delivered quantities by us with the following lot numbers: 3012416/ 31.01.2026; 3058487/ 31.01.2026; 3032920/ 31.01.2026 based on the signed new tender contract with the hospital.Please be aware that complaints have been received from several departments after the replacement of b.Braun¿s stopcocks according to the previous tender contract.

Manufacturer Narrative

Our quality engineer inspected the 1 photo submitted for evaluation.The reported issue of leakage was not confirmed upon inspection of the photo.The reported defect could not be observed in the photo supplied.A physical sample would be needed to functionally test for the reported defect.Bd cannot confirm the cause of the failures to our manufacturing process since no sample was returned for evaluation.We would be very interested in examining product that does not meet your expectations and our quality standards.Examination of the actual product involved may provide clarification as to the cause of the reported failure.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.We appreciate you taking the time to bring this observation to our attention.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.We regret any inconveniences this incident may have caused you and your facility.

• Brand Name: BD CONNECTA PLUS3 BLUE
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 17987627
• MDR Text Key: 326301359
• Report Number: 9610847-2023-00287
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00382903946020
• UDI-Public: (01)00382903946020
• Combination Product (y/n): N
• Reporter Country Code: BU
• PMA/PMN Number: K974083
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 394602
• Device Lot Number: 3032920
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/09/2023
• 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