MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. CONNECTA PLUS1 360 WHITE BLEND; STOPCOCK

Catalog Number 394910

Device Problems Break (1069); Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/18/2020

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Event Description

It was reported that two connecta plus1 360 white blend experienced device damage/deformation while still considered operable.The following information was provided by the initial reporter: material no.: 394910, batch no.: 0094478.I had two stop cocks fall apart.I feel like this quality is real bad , flimsy an do not stay together.

Manufacturer Narrative

H.6.Investigation: a device history record review was completed by our quality engineer team for provided lot number 0094478.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.As a sample was unavailable for return, a thorough sample investigation could not be completed.Based on the investigation results, an exact cause for this incident could not be identified.See h.10.

Event Description

It was reported that two connecta plus1 360 white blend experienced device damage/deformation while still considered operable.The following information was provided by the initial reporter: material no.: 394910 batch no.: 0094478 i had two stop cocks fall apart.I feel like this quality is real bad , flimsy an do not stay together.

• Brand Name: CONNECTA PLUS1 360 WHITE BLEND
• 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
• MDR Report Key: 11023608
• MDR Text Key: 226814706
• Report Number: 9610847-2020-00414
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 02/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/31/2023
• Device Catalogue Number: 394910
• Device Lot Number: 0094478
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/18/2020
• Initial Date FDA Received: 12/16/2020
• Supplement Dates Manufacturer Received: 02/04/2021
• Supplement Dates FDA Received: 02/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1