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	305506
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261); Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/02/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received indicating that a smiths medical jelco® protectiv® safety i.V.Catheter broke off and remained in the patient.Six hours following, the severed catheter was retrieved.The patient recovered with no adverse effects.
Additional Manufacturer Narrative
Smiths medical received two pieces of one jelco® protectiv® safety i.V.Catheter for analysis in a used condition.Microscopy exam of the catheter determined that at approximately.080" from the distal end of the catheter hub, a semi "v" shaped incision was present.This semi "v" shape incision was found to be consistent with a catheter wall penetration by the j-point cannula.When this failure mode occurs, the catheter tube exhibits a distinct "v" shape cut produced by the needle point.The infusion nurses society standards of practice was reviewed and found the non-supported practices: reinsertion of the needle during initial iv placement; placement of the iv in a joint of flexion where the catheter will be subject to repeated bending/kinking; use of scissors to cut tape when removing an iv catheter may result in inadvertent cutting of the catheter.Based on the evidence the failure mode was determined to be user error and was compromised during use.The root cause suggests that the catheter tube separation suggests that reinsertion of the needle occurred, severing the catheter tubing.

• 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: 7147776
• Report Number: 3012307300-2017-02648
• Device Sequence Number: 2117156
• Product Code: FOZ
• UDI-Device Identifier: 10351688071095
• UDI-Public: 10351688071095
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K990236
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: No Information
• Device Catalogue Number: 305506
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2017
• Supplement Date Received by Manufacturer: 01/11/2018
• Initial Report FDA Received Date: 12/27/2017
• Supplement Report FDA Received Date: 01/16/2018
• 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