MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. JELCO PLUS STRAIGHT PERIPHERAL INTRAVENOUS CATHETE; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM

Catalog Number 7060-AI

Device Problem Difficult to Insert (1316)

Patient Problem Perforation of Vessels (2135)

Event Date 03/28/2023

Event Type  malfunction  

Manufacturer Narrative

Other, other text: d4: udi section is unknown, no product information has been provided to date.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.

Event Description

It was reported that when the catheter was inserted into the patient, it twists, causing damage to the vein, which forces to the catheter to be inserted in the patient again.The customer stated that there was no additional information available for this event.

Manufacturer Narrative

No product has been returned, therefore no failure investigation on the product could be performed.If the product is received, we will reopen the investigation and send a supplemental report.The product's history records were reviewed and there were no non-conformances nor service-related issues that would have resulted in the reported complaint.

• Brand Name: JELCO PLUS STRAIGHT PERIPHERAL INTRAVENOUS CATHETE
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; 1500 eureka park; ashford, kent TN25 4BF; UK TN25 4BF
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 16827823
• MDR Text Key: 314169121
• Report Number: 3012307300-2023-04664
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K990236
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 7060-AI
• Device Lot Number: 4268730
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/11/2023
• Initial Date FDA Received: 04/27/2023
• Supplement Dates Manufacturer Received: 01/25/2024
• Supplement Dates FDA Received: 02/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/13/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1