MAUDE Adverse Event Report: SMITHS MEDICAL CZECH REPUBLIC A. S EPIDURAL MINIPACK SYSTEM; ANESTHESIA CONDUCTION KIT

Catalog Number	100/391/118
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the hinge line of epifuse split while in use with patient.There was a patient involvement and unknown patient harm/adverse event reported.
Additional Manufacturer Narrative
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 information becomes available.
Additional Manufacturer Narrative
Investigation summary: one used decontaminated sample of cp1690 catheter connector 19-21g(us) 16-18g(smi) epifuse epidural - luer* was received without its original packaging for investigation.Customer claimed that it was stated that the hinge line of epifuse split while in use with patient.Under visual inspection of the received sample, it was noticed that that hinge line is broken, and the connector is split into 2 parts.The customer's complaint was confirmed.However, no root cause could be determined.This issue is currently monitored by icu medical, there is no trend of confirmed customer complaints.A review of the device history record (dhr) shows there were no observations or nonconformities recorded during manufacture to suggest an issue of this nature would occur with this lot of products.

• Brand Name: EPIDURAL MINIPACK SYSTEM
• Common Device Name: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): SMITHS MEDICAL CZECH REPUBLIC A. S; olomoucká 306; hranice 753 0 1; EZ 753 01
• Manufacturer Contact: reed covert ; 6000 nathan ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 20635067
• Report Number: 3011237704-2024-00243
• Device Sequence Number: 7471003
• Product Code: CAZ
• UDI-Device Identifier: 15019315023460
• UDI-Public: (01)15019315023460(17)281005(10)4388659
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K965017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/23/2024

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: 100/391/118
• Device Lot Number: 4388659
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/01/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2024
• Supplement Date Received by Manufacturer: 11/26/2024
• Initial Report FDA Received Date: 11/07/2024
• Supplement Report FDA Received Date: 12/23/2024
• 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