MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD STPCK Q-SYTE WHT 360DEG W/O NUT CAP NS; STOPCOCK, I.V. SET

Catalog Number 395242

Device Problem Leak/Splash (1354)

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

Event Date 01/30/2024

Event Type  malfunction  

Manufacturer Narrative

H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.

Event Description

It was reported that bd stpck q-syte wht 360deg w/o nut cap ns leaked the following information was provided by the initial reporter: this is a complaint about liquid leaking.It was reported that liquid leaks even when the three-way valve is closed.

Manufacturer Narrative

Our quality engineer inspected the 2 photos and 1 sample submitted for evaluation.The reported issue of leakage was not confirmed upon inspection and testing of the sample.Analysis of the sample showed that there were no observable defects present.The sample underwent leakage testing, and no signs of leakage were observed.Bd could not determine a manufacturing related root cause since the reported defect was not confirmed during the evaluation of the sample.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.We appreciate you taking the time to bring this observation to our attention.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.We regret any inconveniences this incident may have caused you and your facility.

Event Description

No additional information provided.

• Brand Name: BD STPCK Q-SYTE WHT 360DEG W/O NUT CAP NS
• Type of Device: STOPCOCK, I.V. SET
• 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18768232
• MDR Text Key: 336965240
• Report Number: 9610847-2024-00038
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 395242
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/25/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1