MAUDE Adverse Event Report: FULL KIT 22G X 8 CM WITH BIOPATCH AND PROBE COVER; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number	N/A
Medical Device Problem Codes	Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and is pending evaluation.Results are expected soon.A lot history review (lhr) of refs4749 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported by healthcare professional "we had a powerglide issue on friday.Went to place, she said the access and wire deployment went in fine without feeling any issues.She went to thread the catheter and it didn't go.Attempted to pull back on the catheter and wire but both were stuck.She pulled everything out entirely and found that the wire was completely bent backwards, and the needle was through the catheter.They did measurements and ensured everything came out.".
Additional Manufacturer Narrative
H11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.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 the catheter being perforated by the needle and the guidewire being bent was confirmed.The product returned for evaluation was one 22ga x 8cm powerglide pro midline catheter assembly.Usage residues were observed throughout the sample.The guidewire was advanced.Multiple bends were observed in the guidewire, which was intact.The needle protruded from the catheter approximately 3cm from the distal tip.Microscopic inspection of the split in the catheter revealed a glossy fracture surface.A longitudinally aligned scoring mark was observed on the inside surface of the catheter leading into the fracture surface.Microscopic inspection of the catheter tip revealed deformation.The catheter perforation was consistent with damage caused by contact with the tip of the introducer needle.The guidewire bends and catheter tip deformation were consistent with damage caused by attempted insertion/advancement against resistance, such as into tissue.It appeared that initial resistance was encountered during attempted device placement, followed by catheter withdrawal onto the introducer needle.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.¿.
Event or Problem Description
It was reported by healthcare professional "we had a powerglide issue on friday.Went to place, she said the access and wire deployment went in fine without feeling any issues.She went to thread the catheter and it didn't go.Attempted to pull back on the catheter and wire but both were stuck.She pulled everything out entirely and found that the wire was completely bent backwards, and the needle was through the catheter.They did measurements and ensured everything came out.".

• Brand Name: FULL KIT 22G X 8 CM WITH BIOPATCH AND PROBE COVER
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• MDR Report Key: 12517140
• Report Number: 3006260740-2021-03926
• Device Sequence Number: 17216158
• Product Code: FOZ
• UDI-Device Identifier: 00801741140693
• UDI-Public: (01)00801741140693
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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,Followup
• Report Date (Section B): 10/04/2021

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: F322088PT
• Device Lot Number: REFS4749
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2021
• Initial Date Received by Manufacturer: 09/01/2021
• Supplement Date Received by Manufacturer: 10/04/2021
• Initial Report FDA Received Date: 09/22/2021
• Supplement Report FDA Received Date: 10/12/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2021
• 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: 76 YR
• Patient Weight: 77