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

Catalog Number 394995

Device Problem Filling Problem (1233)

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

Event Date 01/08/2021

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: a device history record review could not be performed on model 394995 because a lot number was not provided by the customer.As a sample was unavailable for return, a thorough sample investigation could not be completed.Based on the investigation results, an exact cause for this incident could not be identified.There are quality controls currently in place to detect this type of defect during the production process.Two quality alerts have been issued for this defect.Further action has not been determined necessary at this time.Our quality team will continue to monitor the manufacturing process for this defect and other emerging trends investigation conclusion: this failure mode is usually presented by the variation of the length of the tube, the actions that have been taken to mitigate the problem, are two generate quality alerts and an inspection for each shift to verify that the lengths of the tube are the indicated ones, in the same way, work continues to find opportunities for improvement.There have been no changes in raw materials or operations that could contribute to this failure mode.We will keep monitoring the manufacturing process and in case any emerging trend is detected, further actions will be taken if necessary.

Event Description

It was reported that the bd connecta¿ stopcock experienced kinked tubing.The following information was provided by the initial reporter: the customer has sent us feedback that the experience lately has been that the product kinks below the luer connector much easier than before.

• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 11516819
• MDR Text Key: 240816580
• Report Number: 9610847-2021-00105
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 394995
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/19/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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