MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. JELCO PROTECTIV PLUS-W SAFETY I.V. CATHETERS- WING; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM L

Model Number	308600
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	Pain (1994)
Date of Event	02/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the staff have complained that the substitution with wing is not as good as the previous catheter.The needle is dull in comparison and patients are complaining of pain on insertion.
Additional Manufacturer Narrative
Other text: additional information in d10, h3, h6.This mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).A product sample was received for evaluation.Visual inspection was performed.The visual analysis of the returned samples didn't show any anomaly.The needle was sharp, and the bevel measurements were in compliance with the internal specification.The reported issue could not be confirmed.Therefore, the root cause of the reported issue could not be determined.No further action will be implemented at this time.No problems or issues were identified during this device history record review.D5 is unknown.

• Brand Name: JELCO PROTECTIV PLUS-W SAFETY I.V. CATHETERS- WING
• Common Device Name: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM L
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 201 west queen st.; southington CT 06489
• Manufacturer (Section G): NULL; 201 west queen st.; southington CT 06489
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 13667502
• Report Number: 3012307300-2022-04344
• Device Sequence Number: 11985292
• Product Code: FOZ
• UDI-Device Identifier: 10351688071316
• UDI-Public: 10351688071316
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K990236
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2023

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
• Device Expiration Date: 09/21/2024
• Device Model Number: 308600
• Device Catalogue Number: 308600
• Device Lot Number: 4178060
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2022
• Supplement Date Received by Manufacturer: 02/16/2023
• Initial Report FDA Received Date: 03/04/2022
• Supplement Report FDA Received Date: 04/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2021
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown