MAUDE Adverse Event Report: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. MEDEX MICRO BORE EXTENSION SET W/ FILTER; FILTER, INFUSION LINE

Catalog Number FS116

Device Problem Fluid/Blood Leak (1250)

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

Event Date 10/05/2023

Event Type  malfunction  

Manufacturer Narrative

Manufacture date are unknown; no information has been provided to date.D5.Other operator of device: operator of device is unknown.E.4.Fda notified?: the initial reporter also notified the fda via medwatch # mw5150083.H3.Reason device not evaluated by mfg: other; device was not returned to manufacturer.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.

Event Description

It was reported that the tubing leaked at the filter or required excess pressure to prime/infuse fluid.This occurred during patient infusion, but there was no patient harm/adverse event reported.

Manufacturer Narrative

Device evaluation: no product sample nor pictures were received for analysis; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed.No lot number has been provided, therefore no device history report (dhr) review could be performed.If the product is returned, the manufacturer will reopen this complaint for further investigation.

• Brand Name: MEDEX MICRO BORE EXTENSION SET W/ FILTER
• Type of Device: FILTER, INFUSION LINE
• Manufacturer (Section D): SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.; carretera miguel alemán km21.7; apodaca nuevo leon ; MX
• Manufacturer Contact: reed covert ; 6000 nathan lane n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 18783110
• MDR Text Key: 337419773
• Report Number: 9616567-2024-00034
• Device Sequence Number: 1
• Product Code: FPB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K860803
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility
• Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date: 04/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: FS116
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/07/2024
• 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