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

Catalog Number 395240

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/01/2018

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.Device manufacture date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.

Event Description

It was reported that the septum of a bd connecta¿ stopcock was detached.There was no report of exposure, injury or medical intervention.

Manufacturer Narrative

Investigation summary: lot analysis: the lot number associated with this incident was unknown.Visual analysis: observations and testing: received a 3 way stopcock assembly with an extension set.The assembly consisted of a stopcock with an extension tubing bonded to one of its ports, a full q-syte assembly connected to another and a partial (top only) q-syte assembly bonded to the last of it ports.The partial assembly was missing the neck and the septum assembly.Visual/microscopic examination: observed the missing components of the q-syte (partial) unit had been separated at the weld joint.Observed traces of weld were present at the remainder component (partial q-syte).The weld was adequate and acceptable per specification.Observed there was damage (breakage) on the q-syte (full assembly) bottom body.Observed there was damage (breakage) on the stopcock valve (where the q-syte full assembly was connected).Investigation samples(s) meet manufacturing specifications: no.The upper components of a q-syte assembly were missing (detached).Damage (breakage) was observed on one of the stopcock ports and on the full q-syte assembly.Conclusions: confirmed the upper components of a q-syte assembly were missing (detached) and damage (breakage) was observed on one of the stopcock ports and on the full q-syte assembly.Root cause: relationship of device to the reported incident: indeterminate.Separation at the weld joint: traces of a weld line on the rim of the q-syte assembly; is an indication that a bond was provided during the manufacturing process.A definite cause that contributed to the separation could not be determined.Damage (breakage): damage appears to be caused by external forces applied to the unit during usage.

• 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
• MDR Report Key: 7396978
• MDR Text Key: 104545686
• Report Number: 9610847-2018-00076
• 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: 05/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 395240
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 03/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other