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

Model Number	405511
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/12/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received indicating that a smiths medical jelco® iv catheter severed in a patient's arm.The severed piece of catheter was successfully surgically removed.There were no further adverse effects reported.
Additional Manufacturer Narrative
No product was returned for analysis.However, one picture of the jelco® conventional iv catheter was revealing that the tube was cut in two parts near the bevel.Without the defective unit, we couldn't carry out the failure investigation.No testing or visual inspection could be performed, as no product was made available for evaluation.However, from the returned picture it is possible to see that the tube was cut in two part near the bevel.It is improbable that such type of damage may have been originated during the manufacturing process but from experience that when a cannula is broken into two parts it could be due to: a needle reinsertion or use of a lancet or a scissor near the catheter.

• Brand Name: JELCO® IV CATHETER
• Common Device Name: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): SMITHS MEDICAL ASD; INC.; 6000 nathan lane n; minneapolis, MN 55442
• MDR Report Key: 9594310
• Report Number: 3012307300-2020-00291
• Device Sequence Number: 3170940
• Product Code: FOZ
• UDI-Device Identifier: 15019315118364
• UDI-Public: 15019315118364
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 02/25/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/18/2022
• Device Model Number: 405511
• Device Catalogue Number: 405511
• Device Lot Number: 3766926
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2019
• Supplement Date Received by Manufacturer: 01/27/2020
• Initial Report FDA Received Date: 01/15/2020
• Supplement Report FDA Received Date: 02/26/2020
• 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