MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. JELCO PROTECTIVE PLUS PU SAFETY CATHETER; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Catalog Number	306301
Medical Device Problem Codes	Crack (1135); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No device or device photo was returned for investigation.Due to this, no root cause was determined.The device history review of the reported lot number found no non-conformities during the manufacturing process.
Event or Problem Description
It was reported that bleeding was noted from yellow hub of iv and not from the actual connection.The iv was found to be cracked and therefore leaking.There was patient involvement and no apparent patient harm reported.
Additional Manufacturer Narrative
Investigation summary: the affected device was not returned for evaluation.Two photos were returned for analysis and available for investigation.The first photo displays a 24g protectiv plus catheter assembly attached to a third-party extension set with evidence of blood residue between the catheter hub luer od and extension set luer id.The second photo displayed the blister package top stock confirming the affected product.Given the resolution of the photo, it was difficult to visualize any cracks on the hub, which would indicate different failure modes related to the manufacturing process, mishandling post-manufacturing or a variation in technique when connecting the catheter hub luer to the third-party iv extension set.Root cause could not be defined with confidence based on the photos.Review of manufacturing logbooks identified no definitive root cause for the reported complaint.Based on photos analysis, the complaint cannot be confirmed as a manufacturing related nonconformance.The reported event could not be verified and/or confirmed with confidence, therefore, no further correction, corrective or preventive actions will be conducted by the manufacturing facility at this time.Complaint information will continue to be monitored.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.

• Brand Name: JELCO PROTECTIVE PLUS PU SAFETY CATHETER
• Common Device Name: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 201 west queen st; southington CT 06489
• Manufacturer Contact: reed covert ; 6000 nathan lane n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 19610695
• Report Number: 1219611-2024-00018
• Device Sequence Number: 8486275
• Product Code: FOZ
• UDI-Device Identifier: 10351688071224
• UDI-Public: (01)10351688071224(17)261024(10)4436828
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2024

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: 306301
• Device Lot Number: 4436828
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/14/2024
• Supplement Date Received by Manufacturer: 08/15/2024
• Initial Report FDA Received Date: 06/25/2024
• Supplement Report FDA Received Date: 09/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/27/2023
• 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