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

Catalog Number	305506
Medical Device Problem Codes	Break (1069); Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 catheter tip was not present upon removal from patient¿s arm at time of discharge.Staff thought that the catheter broke off from hub in two different patients.There was a patient involvement and no patient or clinician injury.After the iv catheter was visualized in the patient¿s arm, the vascular team was consulted to remove it from the patient¿s vein.The patient was taken to the operating room, and a cephalic vein ligation was performed.The patient remained in the hospital after surgery an additional day and was discharged on (b)(6) 2025.
Additional Manufacturer Narrative
H3: three photos were provided for review.The product was not returned for analysis.A used protectiv catheter attached to an extension set and removed from the patient's dressing at the flexion joint (elbow) with no catheter tube visible was observed, along with a severed catheter tube.The photos are consistent with the complaint description.Based on resolution of photo, root cause could not be defined with confidence.Given no product was returned, the investigation could not determine the exact cause.A device history review was performed and no discrepancies or abnormalities relevant to the complaint were identified.

• Brand Name: JELCO SAFETY PROTECTIV CATHETERS
• 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: 22096473
• Report Number: 3012307300-2025-06274
• Device Sequence Number: 17869065
• Product Code: FOZ
• UDI-Device Identifier: 10351688071095
• UDI-Public: (01)10351688071095(17)270918(10)6054240
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 305506
• Device Lot Number: 6054240
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2025
• Supplement Date Received by Manufacturer: 06/17/2025
• Initial Report FDA Received Date: 05/28/2025
• Supplement Report FDA Received Date: 07/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/11/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Sex: Unknown
• Patient Weight: 113 KG
• Patient Ethnicity: Non Hispanic