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

Catalog Number	FS116
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: date of event is unknown; no information has been provided to date.D9: date returned to mfg is unknown; no information has been provided to date.D4: expiration date and h4: manufacture date are unknown, invalid lot number provided by the customer.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 or Problem Description
It was reported that fluid was leaking from the filters and not the tubing fittings entering or exiting the filter.Three (3) tubing sets are affected.Product failures occurred during infusion, noticed hours or days into infusion.All affected product labeled and dated by the nursing staff (number of days on patient, lot number, and date).There was no patient harm reported.Possible lot numbers reported were: r23h04093 and r23g31086.
Additional Manufacturer Narrative
D9: date returned to mfg.: 2/6/2024.H3 and h6.Evaluation codes: updated.Device evaluation: three used extension sets were returned.One of the three was connected to a 20ml luer lock syringe with epinephrine which was removed for testing.Each returned sample was leak tested.Leakage observed at the bond between the tubing and inline filter bond at the distal end of the filter.Subsequent examination revealed an incomplete bond between the tubing and the filter bond pocket.The complaint was confirmed.The most probable cause of the condition identified is related to the solvent bonding process executed incorrectly during assembly.A device history record (dhr) review could not be performed as the lot number provided by the customer doesn´t correspond to an icu medical lot number.Awareness was made to operation personnel and the issue will be monitored for threshold or escalation.

• Brand Name: MEDEX IV FILTER EXTENSION SET
• Common Device Name: 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 north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 18742063
• Report Number: 9616567-2024-00026
• Device Sequence Number: 6380728
• Product Code: FPB
• UDI-Device Identifier: 10351688510969
• UDI-Public: 10351688510969
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K860803
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: FS116
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2024
• Supplement Date Received by Manufacturer: 03/20/2024
• Initial Report FDA Received Date: 02/20/2024
• Supplement Report FDA Received Date: 04/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown