MAUDE Adverse Event Report: SMITHS MEDICAL ITALIA SRL JELCO PROTECTIV SAFETY IV CATHETER; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM

Catalog Number	308000---801
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3.Date of event: unknown.No information has been provided to date.Investigation summary: the affected device was returned for evaluation.It has been visually inspected to check any anomaly that could have been resulted in resistance during the venipuncture.No anomalies were detected related to the shape of the needle or catheter.Difficulties during the insertion could potentially be related to bevel defects so its characteristics (trim length and wall thickness) have been measured.There is an imperfect bevel with bevel tip damage that reduces functionality of the catheter.Based on the results achieved, there is no evidence that the product does not comply with the specifications.All the tests applicable to the alleged defect have been performed on the unused returned sample confirming it a compliant product, therefore the complaint 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.The root cause not found since the complaint is not confirmed.Based on the evidence available, the reported allegation is not confirmed therefore no action will be implemented at this time.Complaints data will continue to be monitored.
Event or Problem Description
It was reported a difficulty in pricking the patient and getting into the vein.The catheter hangs in the patient's vein and in some cases, they failed to introduce the catheter to the patient even after 4 attempts.There was patient involvement and unknown patient harm reported.

• Brand Name: JELCO PROTECTIV SAFETY IV CATHETER
• Common Device Name: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM
• 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: 20156907
• Report Number: 3004187702-2024-00034
• Device Sequence Number: 19892679
• Product Code: FOZ
• UDI-Device Identifier: 10351688071330
• UDI-Public: (01)10351688071330(17)270416(10)6005271
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K030571
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/06/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 308000---801
• Device Lot Number: 6005271
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2024
• Initial Report FDA Received Date: 09/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown