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

Catalog Number	305706
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	02/01/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a jelco® protectiv® safety i.V.Catheter was dull, causing patient "discomfort".No injury was reported.
Additional Manufacturer Narrative
One used locked needle guard assembly was received for investigation.The actually catheter was not returned for evaluation and therefore could not be examined or evaluated.The returned sample was examined under magnification and photographed.The photos display evidence of dried blood residue in cannula point and flash chamber.There was no visual evidence of any burrs, hooks or any potential needle point damaged.As part of the investigation, the device was manually unlocked, the sample advanced smoothly, clicked, and locked as designed with no manufacturing nonconformances.

• Brand Name: JELCO® PROTECTIV® SAFETY I.V. CATHETER
• 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: 7332053
• Report Number: 3012307300-2018-00570
• Device Sequence Number: 10789371
• Product Code: FOZ
• UDI-Device Identifier: 10351688071149
• UDI-Public: 10351688071149
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K990236
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2018

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: No Information
• Device Expiration Date: 05/19/2020
• Device Catalogue Number: 305706
• Device Lot Number: 3436748
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/01/2018
• Supplement Date Received by Manufacturer: 03/27/2018
• Initial Report FDA Received Date: 03/12/2018
• Supplement Report FDA Received Date: 04/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1