MAUDE Adverse Event Report: SMITHS MEDICAL ITALIA SRL JELCO PROTECT IV PLUS PU WINGED SAFETY ACTIVE CATHETER; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Model Number 308600

Device Problem Difficult to Insert (1316)

Patient Problem Insufficient Information (4580)

Event Date 01/09/2024

Event Type  malfunction  

Event Description

It was reported that the catheter had difficulty piercing and catheterizing the patient's veins and was more flexible than usual.As a result, the patient needed to be poked several times.A complete assessment was done on the patient, who presented with the adverse event group for a deterioration in his general condition.A vein guard and iv insulin were also used for the patient.

Manufacturer Narrative

E1.Initial reporter phone#: (b)(6).H3.Reason device not evaluated by mfg: other; device was not returned to manufacturer.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.

Manufacturer Narrative

Device evaluation: no product sample or photographs were received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed.A review of the device history record (dhr) shows there were no observations or nonconformities recorded during manufacture to suggest an issue of this nature would occur with this lot of products.If the product is returned, the manufacturer will reopen this complaint for further investigation.Complaints data will continue to be monitored.

• Brand Name: JELCO PROTECT IV PLUS PU WINGED SAFETY ACTIVE CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): SMITHS MEDICAL ITALIA SRL; via della stazione, 2; latina scalo ; IT
• Manufacturer Contact: reed covert ; 6000 nathan lane n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 18672503
• MDR Text Key: 334950344
• Report Number: 3004187702-2024-00001
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K990236
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/14/2024

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 308600
• Device Catalogue Number: 308600---801
• Device Lot Number: 4428988
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/15/2024
• Initial Date FDA Received: 02/08/2024
• Supplement Dates Manufacturer Received: 02/16/2024
• Supplement Dates FDA Received: 03/14/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/22/2023
• 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
• Treatment: BLOOD THINNERS; IV INSULIN; VEIN GUARD
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 83 KG