MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. JELCO PROTECTIV FEP STRAIGHT SAFETY CATHETER; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Catalog Number	305006
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 or Problem Description
It was reported that the catheter leaked during use with the patient.There was no patient harm/adverse event reported.
Additional Manufacturer Narrative
D9.Date returned to mfg: 24-feb-2025.H6.Investigation codes: updated.Investigation summary: one hundred and four (104) unopened, unused 22g x 1¿ protectiv sister samples (sku# 305006, lot# 6021646) were returned for analysis.Forty random samples of the returned 104 sister samples were visually examined for cracked catheter hub, eyelet-to-tube tears, punctured catheter, missing adhesive and damaged/missing porous barrier.Twenty of the visually inspected 40 samples were tested for catheter leakage and the remaining twenty for fluid pooling.All evaluated samples were found to be acceptable without failure.Based on analysis, the complaint cannot be confirmed as a manufacturing nonconformance.In process, product is evaluated for catheter leakage and fluid pooling and visually inspected by operators using statistically valid sampling plans at defined intervals.If any nonconformances are found in process, the product is isolated, non-conformed and immediate action is taken to perform corrections.Sampling plans are based on random sampling selection and are designed to provide a high level of assurance that the true fraction defective is less than or equal to the established aql (acceptable quality limit) level for each quality characteristic.In process, to assure that our products meet functional requirements, the dimensions of the catheter components (eyelet/actuator, tubing, and hub) are tightly controlled.During manufacture, our catheters are tested to assure that the tubing will not tear, break or otherwise fail.During manufacture, critical parameters are 100% controlled during the different phases.Once assembled from the tube, eyelet/actuator and hub, the catheters are inspected in-process 100% to demonstrate that the catheter tube is properly secured to the hub.As reported, the reported event could not be verified and/or confirmed with confidence, therefore, no further correction, corrective or preventive actions will be conducted by the manufacturing facility at this time.Complaint information will continue to be monitored.Icu medical regularly reviews and analyzes post-market data for new information or adverse trends, implementing corrections, taking corrective and preventative actions accordingly.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: JELCO PROTECTIV FEP STRAIGHT SAFETY CATHETER
• Common Device Name: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 201 west queen st; southington CT 06489
• Manufacturer Contact: reed covert ; 6000 nathan ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 20798532
• Report Number: 1219611-2024-00057
• Device Sequence Number: 15161841
• Product Code: FOZ
• UDI-Device Identifier: 10351688071118
• UDI-Public: (01)10351688071118(17)270621(10)6021646
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: UNKNOWN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2025

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: 305006
• Device Lot Number: 6021646
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2024
• Supplement Date Received by Manufacturer: 03/28/2025
• Initial Report FDA Received Date: 11/27/2024
• Supplement Report FDA Received Date: 04/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/15/2024
• 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