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

Catalog Number 394995

Device Problems Detachment Of Device Component (1104); Component Falling (1105); Loose or Intermittent Connection (1371)

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

Event Date 04/27/2018

Event Type  malfunction  

Manufacturer Narrative

Two potential lot numbers were provided for this incident.The information for each lot number is as follows:  medical device lot #: 7354844, medical device expiration date: 2020-11-30,  device manufacture date: 2018-01-19.Medical device lot #: unknown, medical device expiration date: unknown,  device manufacture date: unknown.(b)(6).Investigation results: summary: a photo was provided for analysis.The provided photo was reviewed and our quality engineer was unable to determine a root cause for this occurrence.A review of the device history records revealed no irregularities during the manufacture of the reported lot.Examination of the product involved may provide clarification as to the cause for the reported failure.Conclusion: bd was not able to duplicate or confirm the customer¿s indicated failure mode.Customer reported cap detachment issues; however, no sample was available for evaluation which is essential to perform a better investigation, picture do not help us to confirm the incident and/or determine how this was caused.Quality records have been consulted for tracking and trending purposes and no issues like these are detected which means pretty low occurrence.Product is functional tested and no incidents with plug removals have been reported.Process (b)(4) was reviewed and there are proper controls in place to detect product malfunctions.Root cause: based on investigation results to date, root cause for manufacturing process cannot be determined.

Event Description

It was reported that the caps on bd connecta¿ plus stopcock with extension lines are loose and sometimes fall off which result in sterile breach of the product.There was no report of exposure, serious injury or medical intervention.

Manufacturer Narrative

Event or problem description updated: additional information was received from the customer stating there were 10 other occurrences with unknown dates reported for this same incident.

Event Description

It was reported that the caps on bd connecta¿ plus stopcock with extension lines are loose and sometimes fall off which result in sterile breach of the product.Additional information was received from the customer stating there were 10 other occurrences with unknown dates reported for this same incident.There was no report of exposure, serious injury or medical intervention.

• Brand Name: BD CONNECTA¿ PLUS STOPCOCK WITH EXTENSION LINE
• 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: 7534240
• MDR Text Key: 109008918
• Report Number: 9610847-2018-00143
• 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,health professional,o
• Type of Report: Initial,Followup
• Report Date: 05/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 394995
• Device Lot Number: SEE H.10.
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other