MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. JELCO SAFETY PROTECTIV PLUS CATHETERS; CATHETER, INTRAVASCULAR, THERAPEUTIC,

Model Number	306501
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	08/20/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device is blunt and does not pierce the patient' skin.It took several punctures were necessary to get it right.No medical or surgical intervention was reported.
Additional Manufacturer Narrative
This mdr was generated under protocol b10010116, as a result of warning letter cms#(b)(6).No problems or issues were identified during this device history record review.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 PROTECTIV PLUS CATHETERS
• Common Device Name: CATHETER, INTRAVASCULAR, THERAPEUTIC,
• 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: 16850827
• Report Number: 3012307300-2023-04854
• Device Sequence Number: 6771368
• Product Code: FOZ
• UDI-Device Identifier: 10351688071163
• UDI-Public: 10351688071163
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K990236
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/02/2023

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 Model Number: 306501
• Device Catalogue Number: 306501
• Device Lot Number: 3981786
• 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: 04/24/2023
• Initial Report FDA Received Date: 05/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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