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

Catalog Number 394995

Device Problem Leak/Splash (1354)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/08/2020

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 the caps on 10 bd connecta¿ stopcocks weren't attached properly and fell off when opening up the packaging.The following information was provided by the initial reporter: "during fall 2020, on several occasions, the cap for the side connector on the stop cock has not been attached properly and falls off very easily when opening or even touching the package.".

Manufacturer Narrative

H6: investigation summary a device history record review was completed for provided lot number 0062972.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were originally found to be within specification.As neither picture nor physical samples were available for return, a thorough sample analysis could not be completed by our quality engineer team.Based on the limited investigation results, an exact cause related to the manufacturing facility could not be determined for this incident.It is necessary to check the plugs for tightness prior to use, as noted in the product¿s instructions for use.Further action has not been determined necessary at this time.

Event Description

It was reported that the caps on 10 bd connecta¿ stopcocks weren't attached properly and fell off when opening up the packaging.The following information was provided by the initial reporter: "during fall 2020, on several occasions, the cap for the side connector on the stop cock has not been attached properly and falls off very easily when opening or even touching the package.".

• 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
• MDR Report Key: 11132038
• MDR Text Key: 225536929
• Report Number: 9610847-2021-00002
• 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: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 04/21/2021

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: 02/28/2023
• Device Catalogue Number: 394995
• Device Lot Number: 0062972
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/09/2020
• Initial Date FDA Received: 01/07/2021
• Supplement Dates Manufacturer Received: 04/21/2021
• Supplement Dates FDA Received: 05/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1