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

Catalog Number 395242

Device Problem Leak/Splash (1354)

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

Event Date 08/06/2023

Event Type  malfunction  

Event Description

It was reported that chamotidine leaked from the center of the bd stopcock¿ during use.The following information was provided by the initial reporter, translated from japanese: "this is a report about leakage.Leakage was observed anywhere of the iv set.Material# 385531-zat (information initially provided by the distributor was incorrect) details: (b)(6) started using soldem 1 at 500 ml/day for continuous dosing.On (b)(6), a bolus of chamotidine was administered from the third activity, and leakage was observed from the center of the three-way stopcock.".

Manufacturer Narrative

D.4.Medical device expiration date: unknown.H.3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.H.4.Device manufacture date: unknown.

Manufacturer Narrative

(b)(4)follow up for device evaluation it was reported there is leakage from the infusion line.To aid in the investigation, one sample and five photos were provided for evaluation by our quality team.A visual inspection was performed, and no defects were found.A functional test was performed under water and bd was able to confirm the defect.However, this was initially determined to be related to the molding of the part as the tap component was observed to be perforated.A mold malfunction, mold availability, or production disruption may cause a water leak in the device.After further investigation, and communication with the molding department, the damaged part was scanned, and it was discovered that the hole resembles damage done by a cannula.The pictures captured during the scanning of the device are attached.The damage does not resemble any molding defect.This damage may have occurred during use, but the root cause was not determined.As the lot provided is 'unknown,' a device history record review could not be completed.Based on the investigation, the complaint of a leak from the 3-way stopcock was confirmed.

Event Description

No additional information received this is a report about leakage.Leakage was observed anywhere of the iv set.Material# 385531-zat (information initially provided by the distributor was incorrect) details: (b)(6) started using soldem 1 at 500 ml/day for continuous dosing.On (b)(6) a bolus of chamotidine was administered from the third activity, and leakage was observed from the center of the three-way stopcock.

• Brand Name: BD 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: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17620790
• MDR Text Key: 321936657
• Report Number: 9610847-2023-00239
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/01/2023

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 Catalogue Number: 395242
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/07/2023
• Initial Date FDA Received: 08/24/2023
• Supplement Dates Manufacturer Received: 11/01/2023
• Supplement Dates FDA Received: 10/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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