MAUDE Adverse Event Report: ACCUCATH ACE INTRAVASCULAR KIT CATHETER (22G); CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Activation Problem (4042)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of refp2302 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported a catheter i placed on a (b)(6) in the forearm the guide wire advanced there was blood return in the catheter, the catheter threaded smooth and when i hit the button the guide wire got hung up on the catheter and kinked it under the skin and i had to pull back on both for the needle to fulling retract.Placement technique: ultrasound guided.Was there any patient harm reported? no harm, just additional needle poke for placement.Weight: about (b)(6).What they¿re being treated for: work up for abdominal pain.

• Brand Name: ACCUCATH ACE INTRAVASCULAR KIT CATHETER (22G)
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• MDR Report Key: 12683409
• Report Number: 3006260740-2021-04476
• Device Sequence Number: 3751219
• Product Code: FOZ
• UDI-Device Identifier: 00801741137990
• UDI-Public: (01)00801741137990
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K162894
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/01/2021

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: N/A
• Device Catalogue Number: AC1221252
• Device Lot Number: REFP2302
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/28/2021
• Initial Report FDA Received Date: 10/22/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2021
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 11 YR
• Patient Weight: 41