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

Catalog Number 395242

Device Problems Break (1069); Leak/Splash (1354)

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

Event Date 12/12/2022

Event Type  malfunction  

Event Description

It was reported that the bd stopcock¿ was damaged and caused saline to leak out from the connection to the surplug ad extension tubing.The following information was provided by the initial reporter, translated from japanese: "this is a report about saline leakage from the connection to surplug ad extension tubing.The customer reported as follows: during priming with saline before administration in a hospital ward, the nurse noticed the saline was leaking from the connection between 515547-zat and the surplug ad extension tubing.".

Manufacturer Narrative

Medical device expiration date: na.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 stopcock¿ was damaged and caused saline to leak out from the connection to the surplug ad extension tubing.The following information was provided by the initial reporter, translated from japanese: "this is a report about saline leakage from the connection to surplug ad extension tubing.The customer reported as follows: during priming with saline before administration in a hospital ward, the nurse noticed the saline was leaking from the connection between 515547-zat and the surplug ad extension tubing.".

Manufacturer Narrative

H6: investigation summary: it was reported saline was leaking from the connection.To aid in the investigation, one sample was received for evaluation by our quality team.A visual inspection was performed and no defects were found in the connecta.Additionally, a leak test was performed under water and the sample did not leak.Damages like these on the stopcock do not occur during production.The appearance of these cracks is typical and can occur when the product has been used together with lubrication solution or infusion with high ph-value.These solutions can release internal stress in the product.If excessive force is used when connecting and using the product for more than 24 hours, this may cause the material to crack.A device history record review was completed for provided material number 515547-zat, lot 2208012c and no anomalies were found.An additional device history was reviewed for the batch of the reported defective component used in the manufacturing of this unit.According to the documented records, the product was manufactured according to the approved manufacturing procedures, specifications, and then released by quality assurance.There were no nonconformance(s), capas or abnormal conditions noted at the time of production.At the time of the dhr review, there were no changes to the process and/or equipment that would have affected the manufacturing of the device.Bd was not able to confirm the customer¿s indicated failure mode.

• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16493105
• MDR Text Key: 311431701
• Report Number: 9610847-2023-00049
• 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: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 395242
• Device Lot Number: 1335744
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2021
• 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