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 4033-AI

Device Problem Material Fragmentation (1261)

Patient Problem No Code Available (3191)

Event Date 01/25/2019

Event Type  Injury  

Event Description

Information was received that a smiths medical catheter had torn a blood vessel during insertion.The device was reported to have a sandpapery surface at the needle tip.A fragment of the catheter remained in the patient's vessel, and was removed by operation.

Manufacturer Narrative

Correction of evaluation results: one jelco iv catheter was returned for investigation.A visual analysis of the returned product did not show any defects.However a visual analysis of the photograph did show that the tube was cut in the middle.The returned unit did not show any defect, and on the basis of the results achieved, there is no evidence that the product did not comply with the internal specification.

Manufacturer Narrative

Evaluation results: the used jelco safety protect iv catheter was not actually returned for investigation.A photograph of the device involved in the incident was examined.The investigator noted that the defect was of a nature that is usually caused by an improper use of the device (e.G.A needle reinsertion).This hypothesis could not be confirmed however, without inspecting the actual device under magnification.

• 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
• MDR Report Key: 8484381
• MDR Text Key: 140956958
• Report Number: 3012307300-2019-01775
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 08/22/2019

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?: No
• Device Operator: No Information
• Device Expiration Date: 03/22/2023
• Device Catalogue Number: 4033-AI
• Device Lot Number: 3605358
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/06/2019
• Initial Date FDA Received: 04/04/2019
• Supplement Dates Manufacturer Received: 07/02/2019; 07/02/2019
• Supplement Dates FDA Received: 07/10/2019; 08/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention