MAUDE Adverse Event Report: MEDSOURCE LABS, LLC CURAPLEX; CURAPLEX CURASLIDE BLOOD CONTROL 20G X 1IN

Model Number	1613-862202
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Medsource received feedback from our customer stating that: provider had inserted the needle/cathlon in vein, flash detected, started advancing catheter and removing needle.After needle was removed, catheter could not be advanced further to properly place cathlon.When provider went to remove cathlon, it tugged at the skin and finally came out with the end looking busted open.Additionally, they stated that they were not able to get fluids to flow through the product.Due to the possibility of catheter fragments remaining in the vein from the appearance they described in the complaint, it was determined that this was a reportable event.
Additional Manufacturer Narrative
The product was not available to be returned for evaluation.A follow-up mdr report will be filed once we have received the results of the investigation that is being performed on the retention samples for that part and lot number.

• Brand Name: CURAPLEX
• Common Device Name: CURAPLEX CURASLIDE BLOOD CONTROL 20G X 1IN
• Manufacturer (Section D): MEDSOURCE LABS, LLC; 8600 shelby court; suite 100; chanhassen MN 55317
• Manufacturer Contact: neeraj gupta ; 110-111 phase iv; udyog vihar sector 18; grugram, haryana 12201-5 ; IN 122015
• MDR Report Key: 21026499
• Report Number: 3003674698-2024-00843
• Device Sequence Number: 21108876
• Product Code: FOZ
• UDI-Device Identifier: 00810094574178
• UDI-Public: 00810094574178
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K223788
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/27/2024

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 Model Number: 1613-862202
• Device Catalogue Number: 1613-862202
• Device Lot Number: 30862/0537
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2024
• Initial Report FDA Received Date: 12/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/31/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown