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 Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/18/2022

Event Type  malfunction  

Manufacturer Narrative

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 leakage.The following information was provided by the initial reporter: the patient is turned from the back to the left side and after 1 hour it is discovered that it is wet in bed.Detects leakage from the 3-way tap on central venous catheter where insulin and potassium fusion are in progress.No leakage before the patient was turned to the left side in bed.The 3-way tap was changed and rinsed through with salt water after it was removed from the patient.When rinsed, it leaks between 2 taps even though they are encrusted properly.

Event Description

It was reported that the bd connecta¿ stopcock experienced leakage.The following information was provided by the initial reporter: the patient is turned from the back to the left side and after 1 hour it is discovered that it is wet in bed.Detects leakage from the 3-way tap on central venous catheter where insulin and potassium fusion are in progress.No leakage before the patient was turned to the left side in bed.The 3-way tap was changed and rinsed through with salt water after it was removed from the patient.When rinsed, it leaks between 2 taps even though they are encrusted properly.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 11-jan-2023.H6: investigation summary our quality engineer inspected the 1 sample submitted for evaluation.The reported issue of leakage was confirmed upon inspection and testing of the sample.The sample underwent our internal leakage testing and showed leakage.Upon further inspection of the defected sample, cracks were observed connector of the extension.Bd cannot determine a manufacturing root cause since the failure cannot be replicated in our manufacturing process.The most probable root cause could be excessive force applied to the connector after use with a lubrication agent or high ph value infusion.Using such materials with the product can cause internal stresses to release and result in cracking at the connector when excessive force is applied.The device history records (dhr) review was performed for the lot number material identified in this complaint.According to the documented records, the product was manufactured according to the approved manufacturing procedures, specifications, and then released by quality assurance.

• 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
• Manufacturer (Section G): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15902402
• MDR Text Key: 307903615
• Report Number: 9610847-2022-00451
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: NO
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/03/2023

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 Expiration Date: 12/31/2022
• Device Catalogue Number: 394600
• Device Lot Number: 0006976
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/07/2022
• Initial Date FDA Received: 12/02/2022
• Supplement Dates Manufacturer Received: 02/03/2023
• Supplement Dates FDA Received: 02/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/31/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1