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

Catalog Number 394600

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/06/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.(b)(4).

Event Description

It was reported that 4 bd connecta¿ stopcocks experienced leakage.The following information was provided by the initial reporter: last couple of weeks there have been recurring incidents with connectors cracking after connection with other products in the paediatric intensive care unit, which have resulted in leakage.It is unclear if this has lead to under dosage of sedation.Last couple of weeks there have been recurring incidents with connectors cracking after connection with other products.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 2021-01-14 h6: investigation summary to aid in the investigation of this incident, the affected sample was returned for evaluation by our quality engineer team.Through examination of the sample, a crack was identified on the connector section of the product.Damages like this on the stopcock housing component, do not typically occur from the production process.The appearance of these cracks typically result when the product has been used together with a lubricant solution or an infusion with a high ph value.These solutions can stress the formulation of the product.If excessive force is used when connecting the product or if the product is used for over twenty-four hours, cracking may occur.Per the instructions for use, the user should avoid over tightening the connection, check connections regularly, change the stopcock every seventy-two hours, or change the stopcock every twenty-four hours depending on the type of infusate used.At this time, further action has not been determined necessary at the manufacturing facility.Dhr review was not performed because batch was not provided.See h10.

Event Description

It was reported that 4 bd connecta¿ stopcocks experienced leakage.The following information was provided by the initial reporter: last couple of weeks there have been recurring incidents with connectors cracking after connection with other products in the paediatric intensive care unit, which have resulted in leakage.It is unclear if this has lead to under dosage of sedation.Last couple of weeks there have been recurring incidents with connectors cracking after connection with other products.

• 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: 10939266
• MDR Text Key: 226057102
• Report Number: 9610847-2020-00390
• 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: 02/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 394600
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2021
• Initial Date Manufacturer Received: 11/06/2020
• Initial Date FDA Received: 12/03/2020
• Supplement Dates Manufacturer Received: 02/07/2021
• Supplement Dates FDA Received: 02/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1