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

Catalog Number	304806
Medical Device Problem Codes	Dull, Blunt (2407); Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/30/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a jelco® protectiv® safety i.V.Catheter was dull on insertion and dragged on threading and needle insertion.No adverse patient effects were reported.
Additional Manufacturer Narrative
The device history record was reviewed and showed that this device met all manufacturing specification for product released for distribution.No issues were identified that would have impacted this event.One used peripheral intravenous catheter was received for device evaluation.Visual inspection was performed using microscopy in order to detect any potential defects including hooks, burrs, silvers, or point damage.No point associated damage was observed.Measurement of point geometry was performed and the overall bevel length met specification.The complaint was not confirmed.Further analysis was performed to assess for potential difficulty to advance and treading issues.Functional testing was performed using a vein pad and manual advancement.The returned sample advanced smoothly, clicked, and locked as designed without any difficulty.The complaint was not confirmed.While no definitive root cause to the reported issue could be determined, this investigation revealed no intrinsic evidence to suggest a root cause related to manufacturing.

• Brand Name: JELCO® PROTECTIV® SAFETY I.V. CATHETER
• Common Device Name: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS
• Manufacturer (Section D): SMITHS MEDICAL, ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 7482828
• Report Number: 3012307300-2018-01441
• Device Sequence Number: 11148730
• Product Code: FOZ
• UDI-Device Identifier: 10351688071125
• UDI-Public: 10351688071125
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 06/05/2018

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: Health Professional
• Device Expiration Date: 06/24/2020
• Device Catalogue Number: 304806
• Device Lot Number: 3449060
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2018
• Supplement Date Received by Manufacturer: 05/07/2018
• Initial Report FDA Received Date: 05/03/2018
• Supplement Report FDA Received Date: 06/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1