MAUDE Adverse Event Report: BASIC KIT 22G X 8CM WITH BIOPATCH; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, trend analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of difficult device insertion/device damage was confirmed.The product returned for evaluation was one 22ga x 8cm powerglide pro midline catheter assembly.The sample was received assembled.Blood residue was abundant throughout the sample.The catheter was partially advanced.Curved shape memory was observed along the catheter length.The needle shaft was bent within the region of the housing.Microscopic inspection of the distal end of the catheter revealed deformation.Inspection of the catheter shaft revealed a v-shaped split approximately midway along its length.The split exhibited a glossy fracture surface.A longitudinally aligned v-shaped split was observed on the inside surface of the catheter leading into the split.Following removal of the catheter, inspection of the guidewire revealed it to be intact.Curved shape memory was observed along the portion of the guidewire that extended beyond the needle.The curved shape memory and catheter tip deformation were consistent with attempted insertion against resistance, such as into tissue.The catheter split was consistent with subsequent withdrawal of the catheter against the needle tip.The product ifu states ¿warning: once the catheter has been advanced, do not re-insert the needle back into the catheter or pull the catheter back onto the needle.If the catheter needs to be repositioned, either do so without the aid of the needle, or remove both the catheter and the needle as a unit to prevent the needle from damaging or shearing the catheter.¿ a lot history review (lhr) of reev0109 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported "when inserting midline device into patient, guidewire threaded smoothly, however catheter got stuck half way while advancing, needle did not retract.Entire device removed from patients arm intact, vein still appeared intact after inspected w/ultrasound.".

• Brand Name: BASIC KIT 22G X 8CM WITH BIOPATCH
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• MDR Report Key: 12627469
• Report Number: 3006260740-2021-04352
• Device Sequence Number: 3369882
• Product Code: FOZ
• UDI-Device Identifier: 00801741140549
• UDI-Public: (01)00801741140549
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K162377
• 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): 09/27/2021

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: F322087T
• Device Lot Number: REEV0109
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/22/2021
• Initial Report FDA Received Date: 10/13/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2020
• 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: 4 YR