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

Catalog Number	306501
Medical Device Problem Codes	Bent (1059); Material Fragmentation (1261)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	12/11/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that upon the removal of a jelco® protectiv® safety i.V.Catheter, a small area of the catheter appeared to be missing.The catheter was bent and the tip was broken in a "v" shape.The removal of the catheter happened in a medical center.It was reported that the patient had other serious medical event.It was also reported that there were no plans for further intervention and that the patient was discharged from the medical center in stable condition.No other adverse health outcomes were reported.

• Brand Name: JELCO® PROTECTIV® SAFETY I.V. CATHETERS
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): SMITHS MEDICAL, ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 6856050
• Report Number: 3012307300-2017-02000
• Device Sequence Number: 10886463
• Product Code: FOZ
• UDI-Device Identifier: 10351688071163
• UDI-Public: 10351688071163
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K990236
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/11/2017

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/14/2019
• Device Catalogue Number: 306501
• Device Lot Number: 3302979
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/11/2017
• 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: Other
• Patient Age: 32 YR
• Patient Weight: 55