MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. JELCO SAFETY PROTECT IV PLUS CATHETERS; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM L

Model Number	306701
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/07/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported, that the plastic bent on the end, after the needle was retracted.No patient injury was reported.
Additional Manufacturer Narrative
E4: initial reporter, also sent report to fda is unknown.No information has been provided to date.A device history record (dhr) review was conducted, which indicated all inspections were completed.And no issues were noted, during manufacture.No product sample was received.Therefore, visual and functional testing could not be performed.The reported issue could not be confirmed, as no product sample was received for evaluation.If the product is returned, the manufacturer will reopen this complaint for further investigation.

• Brand Name: JELCO SAFETY PROTECT IV PLUS CATHETERS
• Common Device Name: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM L
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 201 west queen st.; southington CT 06489
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 17257775
• Report Number: 3012307300-2023-07018
• Device Sequence Number: 17656923
• Product Code: FOZ
• UDI-Device Identifier: 10351688071217
• UDI-Public: 10351688071217
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K990236
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/05/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/14/2024
• Device Model Number: 306701
• Device Catalogue Number: 306701
• Device Lot Number: 4177471
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2022
• Initial Report FDA Received Date: 07/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/09/2021
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown