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

Catalog Number 394602

Device Problem Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/17/2019

Event Type  malfunction  

Manufacturer Narrative

Device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the connecta plus3 blue experienced leakage prior to use.The following information was provided by the initial reporter: on (b)(6) 2019, received a complaint from foreign user facility and complained that there was a leak in the transparent shell of the connecta.

Event Description

It was reported that the connecta plus3 blue experienced leakage prior to use.The following information was provided by the initial reporter: on (b)(6), 2019, received a complaint from foreign user facility and complained that there was a leak in the transparent shell of the connecta.

Manufacturer Narrative

Investigation: a device history review was conducted for lot number 8310936.Our records show that this is the only instance of this issue occurring in this production batch.According to the sampling plan applied for product performance, this lot was accepted and released without defects being noted during the final assembly or visual inspections.Additionally, a large crack was present in the adapter of the submitted device, this was confirmed by testing to be the only source of leakage present on the device.Our quality engineers were not able to replicate the damage in the manufacturing process, this indicates the defect may have occurred post-manufacture.Based on our observations, the root cause for this complaint could not be determined at the conclusion of our review.

• Brand Name: CONNECTA PLUS3 BLUE
• Type of Device: STOP COCK
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• MDR Report Key: 9145924
• MDR Text Key: 191272123
• Report Number: 9610847-2019-00594
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 11/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 10/31/2021
• Device Catalogue Number: 394602
• Device Lot Number: 8310936
• Initial Date Manufacturer Received: 09/17/2019
• Initial Date FDA Received: 10/02/2019
• Supplement Dates Manufacturer Received: 09/17/2019
• Supplement Dates FDA Received: 11/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other