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

Catalog Number 395217

Device Problems Loose or Intermittent Connection (1371); Structural Problem (2506)

Patient Problem No Patient Involvement (2645)

Event Date 07/13/2018

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.

Event Description

It was reported that a connecta¿ plus stopcock had a loose bar on the stopcock, customer did not use it as it could potentially leak.There was no report of exposure, serious injury or medical intervention.

Manufacturer Narrative

Due to an it issue beginning on (b)(6) 2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: event attributed to: other; device single use?: no; device returned to manufacture: yes.Unfortunately a lot number could not was not submitted for this complaint, and could not be determined from the photographs provided, preventing our investigation team from conducting a device history review.A sample and photograph were provided for the purpose of aiding our quality engineer's investigation.The returned sample was subjected to leakage testing, during which a leak was observed originating from a crack in the housing component of the device.The root cause for this issue could not be determined at this time.Bd will continue to track and trend for this issue.

Event Description

It was reported that a connecta plus stopcock had a loose bar on the stopcock, customer did not use it as it could potentially leak.There was no report of exposure, serious injury or medical intervention.

• Brand Name: CONNECTA¿ PLUS 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
• MDR Report Key: 7744896
• MDR Text Key: 116057382
• Report Number: 9610847-2018-00240
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00382903952175
• UDI-Public: 382903952175
• 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: 09/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 395217
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2018
• Date Manufacturer Received: 07/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other