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

Catalog Number 394995

Device Problem Device Damaged Prior to Use (2284)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/20/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.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 the bd connecta¿ stopcock experienced defective/damaged tubing.The following information was provided by the initial reporter: reference: 394995, lot: 0304073b.The extender is found cut in the intact packaging.

Event Description

It was reported that the bd connecta¿ stopcock experienced defective/damaged tubing.The following information was provided by the initial reporter: reference: 394995, lot: 0304073b.The extender is found cut in the intact packaging.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 2021-06-04.H6: investigation summary: bd received a photo and sample submitted for evaluation.The reported issue was confirmed since the failure was observed by our quality engineer during visual inspection of the sample.Bd was able to confirm the cause of the failure to our manufacturing process.Our automated systems to detect trapped products failed during the production of this product.All necessary repairs were performed on the same day.Bd is also currently working on improvements to our detection systems to further prevent the occurrence of device defects during the manufacturing process.Quality records have been consulted for tracking and trending purposes and this was the first occurrence of this failure mode, which means issues like this are rare.A device history record review showed no non-conformances associated with this issue during the production of this batch.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.

• 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: 12021627
• MDR Text Key: 262768240
• Report Number: 9610847-2021-00277
• 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: 07/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/30/2023
• Device Catalogue Number: 394995
• Device Lot Number: 0304073
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2021
• Date Manufacturer Received: 07/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1