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

Model Number 405511

Device Problem Material Fragmentation (1261)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/12/2019

Event Type  Injury  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 175203018
• Report Number: 3012307300-2020-00291
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 15019315118364
• UDI-Public: 15019315118364
• Combination Product (y/n): N
• PMA/PMN Number: K990236
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 02/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 01/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention