MAUDE Adverse Event Report: SMITHS MEDICAL ITALIA SRL JELCO PROTECTIVE FEP WINGED SAFETY CATHETER; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Catalog Number	307000
Medical Device Problem Codes	Failure to Deliver (2338); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while attempting to place the catheter, it would not advance.The catheter was removed and examined.An outward bevel was noted on the catheter.A new catheter was chosen, and the catheter was placed with no further issues.There was patient involvement and no 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 reportable information becomes available.
Additional Manufacturer Narrative
H6.Investigation codes: updated.Investigation summary: the returned sample has been visually inspected under magnification and appropriate lighting condition.Visual analysis confirmed the defect: the catheter tube appears to be slightly flattened at about 4mm distance from the nose.The protrusion of the catheter contour that results from the deformation is out of specification.Analysis of the returned sample confirmed the defect: a protrusion > 0.001¿ on the catheter contour at about 4mm distance from the nose was detected, which might be related to the issue experienced by the customer.It is possible that the defect originated during the assembly process on the pcm 7 manufacturing line, where probably for an accidental misalignment the unit interfered with a component of the manufacturing machine (damage potentially compatible with the jaws of the vision inspection catheter tip station).Manufacturing records have been checked, finding no maintenance tickets opened, therefore no mechanical machine issues, during the production of the lot involved that would pertain to this issue.In process, the product is tested within the statistical qc checks for any bevel/catheter contour defect.Review of the dhr showed that the qc tests were performed with no anomalies noted: all the samples passed the tests confirming compliance of the product with the specification.Review of the complaint database didn¿t find other complaints on the lot involved.In the last three years (jun2021-jun2024) no other complaint was received reporting a similar defect for the product code 307000.Based on the investigation results, the customer¿s allegation is confirmed, but there is no evidence of a systematic issue, rather the defective unit is probably attributable to an accidental misalignment occurred on the vision inspection catheter tip station.The defective unit may be considered an isolated occurrence.After a complaint trend analysis, no trend was identified for the referenced defect.No corrective action will be implemented at this moment; however, we will monitor the recurrence of this type of defect and if a trend will be identified, a corrective action will be recommended.All justified complaints are discussed during the mrb monthly meeting in order to identify potential trend and preventative or corrective action for the product improvement.Complaints details are also shared with the production floor in order to raise operators¿ awareness on the type of defects reported.

• Brand Name: JELCO PROTECTIVE FEP WINGED SAFETY CATHETER
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): SMITHS MEDICAL ITALIA SRL; via della stazione, 2; latina scalo 0401 ; IT 0401
• Manufacturer Contact: reed covert ; 6000 nathan lane n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 19303338
• Report Number: 3004187702-2024-00005
• Device Sequence Number: 5855181
• Product Code: FOZ
• UDI-Device Identifier: 10351688071262
• UDI-Public: (01)10351688071262(17)260523(10)4392823
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2024

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: 05/23/2026
• Device Catalogue Number: 307000
• Device Lot Number: 4392823
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/30/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2024
• Supplement Date Received by Manufacturer: 06/07/2024
• Initial Report FDA Received Date: 05/13/2024
• Supplement Report FDA Received Date: 07/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/31/2023
• 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