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

Device Problem Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/22/2018

Event Type  malfunction  

Event Description

Information was received indicating that one day following insertion of a smiths medical jelco® protectiv® safety i.V.Catheter, it was noted to be leaking a clear liquid.Upon assessment, the catheter was noted to be broken off 1-2 millimeters from the hub.The rest of the catheter was not present on the patient's skin or the iv dressing.The following day an x-ray was performed noting the catheter in the left arm of the patient.Subsequently, surgical procedure was performed to remove the catheter.There were no reported adverse effects.

Manufacturer Narrative

One a smiths medical jelco® proplusw.Catheter along with an extension set was returned for analysis.The sample was visually inspected under microscopic examination finding that a redirected cannula penetrated the catheter wall during deployment; leaving a classic v shape wall.The penetration was noted at the 6 o'clock location with reference to wing position during deployment.The failure mode is reported to occur when the cannula is partially retracted and then advanced while threading the catheter in to the vein.Based on the evidence, the complaint is confirmed and the root cause is noted to be from user interface.

• Brand Name: JELCO® PROTECTIV® SAFETY I.V. CATHETERS
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis, MN 55442
• Manufacturer (Section G): SMITHS MEDICAL NORTH AMERICA,; 201 west queen street; southington CT 06489
• Manufacturer Contact: dave halverson ; 6000 nathan lane n; minneapolis,, MN 55442 ; 7633833310
• MDR Report Key: 7543415
• MDR Text Key: 109219539
• Report Number: 3012307300-2018-01628
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2018
• Is this an Adverse Event Report?: Yes
• Device Operator: Nurse
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/04/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention