MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. JELCO CONVENTIONAL JELCO IV CATHETERS; CATHETER, INTRAVASCULAR, THERAPEUTIC,

Catalog Number 4036-AI

Device Problem Difficult to Insert (1316)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/01/2022

Event Type  malfunction  

Manufacturer Narrative

Other text: this mdr was generated under protocol (b)(4), as a result of warning letter (b)(4).A product sample was received for evaluation.Visual and functional testing were performed.Investigation of sample found no needle or bevel defects.The catheter contour has been inspected for defects, no asperities observed.The root cause of the reported issue was not able to be determined.No actions were taken to mitigate the reported issue as the issue was not confirmed.No problems or issues were identified during this device history record review.E4: initial reporter also sent report to fda is unknown.G5: premarket (510k) number is unknown.

Event Description

It was reported that the catheter was difficult to insert.Once removed, a slight asperity was discovered in the middle of the catheter.No patient injury was reported.

Manufacturer Narrative

Other, other text: this remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).Please disregard the initial report submitted with the mfr number: 3012307300-2023-05478.The report was submitted in error.

• Brand Name: JELCO CONVENTIONAL JELCO IV CATHETERS
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC,
• 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: 16903496
• MDR Text Key: 314920484
• Report Number: 3012307300-2023-05478
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/26/2023

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: 4036-AI
• Device Lot Number: 4205158
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2022
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/20/2023
• Initial Date FDA Received: 05/10/2023
• Supplement Dates Manufacturer Received: 05/26/2023
• Supplement Dates FDA Received: 05/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1