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

Catalog Number 394982

Device Problem Material Separation (1562)

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

Event Date 07/25/2022

Event Type  malfunction  

Event Description

It was reported that 3-4 unspecified number of bd connecta¿ stopcocks with extension sets experienced the hose coming loose.The following information was provided by the initial reporter: on 3-4 occasions independently of each other, the micro hose came loose from the 3-way tap or from the inner part towards the entrance (cock).On 2 of the occasions, the tube was on a central access, which could potentially have led to air entering the patient's blood system or blood leaking out in larger quantities.

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Bd was unable to perform a thorough investigation as no sample, lot, or batch number were provided.Examination of the product involved may provide clarification as to the cause for the reported failure.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.

Manufacturer Narrative

H.6.Investigation summary: bd was unable to perform a thorough investigation as no sample, lot, or batch number were provided.

Event Description

It was reported that 3-4 unspecified number of bd connecta¿ stopcocks with extension sets experienced the hose coming loose.The following information was provided by the initial reporter: on 3-4 occasions independently of each other, the micro hose came loose from the 3-way tap or from the inner part towards the entrance (cock).On 2 of the occasions, the tube was on a central access, which could potentially have led to air entering the patient's blood system or blood leaking out in larger quantities.

• Brand Name: BD CONNECTA¿ STOPCOCK WITH EXTENSION SET
• 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: 15290729
• MDR Text Key: 303549148
• Report Number: 9610847-2022-00308
• 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: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/01/2022

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: 394982
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/25/2022
• Initial Date FDA Received: 08/25/2022
• Supplement Dates Manufacturer Received: 09/01/2022
• Supplement Dates FDA Received: 09/23/2022
• 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