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

Catalog Number	306301
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device 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 hub was fused" and found during patient use.There was patient involvement, but no harm/adverse event reported.
Additional Manufacturer Narrative
H6.Investigation codes: updated.Investigation summary: two photos were returned for analysis.The photos displayed two used, locked out 24gx ¾" protectiv plus devices without sheaths and with blister packaging.Magnified examination of the nose components displayed evidence of form in place gasket (fipg) adhesive overflow on the nose od in one of the two samples displayed in photo, mechanically locking the catheter hub to the nose and preventing proper disconnection/separation upon insertion, consistent with the reported event (specifically the sample with visible dried blood residue).Due to the resolution of the photo, it could not be determined whether the other sample pictured exhibited the same adhesive overflow condition.Review of the machine logbooks indicates that there was an issue with fipg adhesive overflow on product at pcm3 fipg adhesive dispense station during 1st shift, 24-may-23 and as a correction, the dispensing tip/blunt was repositioned accordingly.The process fmea for pcm3 assembly machine was reviewed for controls in place specific to the fipg adhesive dispense station.Dhr review verified that all routine controls were executed properly & in a timely manner.Based on analysis, the complaint is confirmed as a manufacturing nonconformance.In-process, product is evaluated for force to advance (fta) and force to lock (ftl) 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.Inspections and tests are conducted by trained operators using statistically valid sampling plans at defined intervals.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 level for each quality characteristic.As a correction, this complaint is being communicated to appropriate personnel and an a3 root cause analysis will be performed to identify additional prevention & detection controls.No further correction or corrective 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.

• Brand Name: JELCO SAFETY PROTECTIV PLUS CATHETERS
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan ln n; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 19351016
• Report Number: 3012307300-2024-03928
• Device Sequence Number: 7298540
• Product Code: FOZ
• UDI-Device Identifier: 10351688071224
• UDI-Public: (01)10351688071224(17)260525(10)4401399
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2024

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 Expiration Date: 05/25/2026
• Device Catalogue Number: 306301
• Device Lot Number: 4401399
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2024
• Supplement Date Received by Manufacturer: 05/30/2024
• Initial Report FDA Received Date: 05/20/2024
• Supplement Report FDA Received Date: 06/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/21/2023
• 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