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

Catalog Number 394605

Device Problem Packaging Problem (3007)

Patient Problem Blister (4537)

Event Date 09/02/2020

Event Type  malfunction  

Manufacturer Narrative

There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 8305758, medical device expiration date: 2021-10-31, device manufacture date: 2018-11-26, medical device lot #: 8121546, medical device expiration date: 2021-04-30, device manufacture date: 2018-07-11, medical device lot #: 8243762, medical device expiration date: 2021-07-31, device manufacture date: 2018-09-26.

Event Description

It was reported that 500 bd connecta¿ stopcocks experienced discolored blister packs which was noted prior to use.The following information was provided by the initial reporter: when the outer package is intact and undamaged, the smallest package contamination is found during use.

Event Description

It was reported that 500 bd connecta¿ stopcocks experienced discolored blister packs which was noted prior to use.The following information was provided by the initial reporter: when the outer package is intact and undamaged, the smallest package contamination is found during use.

Manufacturer Narrative

H.6.Investigation: a device history record review was performed for provided lot numbers 8305758, 8243762, and 8121546.The review did not reveal any detected quality issues during the production process that could have contributed to this reported incident.To aid in the investigation of this issue, one picture sample was returned for evaluation by our quality engineer team.Through examination of the picture, excess silicone was observed.It has been determined that this incident resulted from an error in the amount of silicone dispersed within the manufacturing process.A change was initiated to place a silicone sensor within the dispenser machinery to prevent this type of issue from recurring.

• 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: 10578298
• MDR Text Key: 214151299
• Report Number: 9610847-2020-00296
• 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: 10/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 394605
• Device Lot Number: SEE H10
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 09/22/2020
• Date Manufacturer Received: 09/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other