MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 FULL KIT 20G X 8 CM WITH PROBE COVER; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/20/2024
Type of Reportable Event	Malfunction
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 complaint of difficult catheter insertion was confirmed and was determined to be use related.The product returned for evaluation was a 20ga x 8cm powerglide pro midline catheter assembly.The device was received fully assembled and the guidewire was fully advanced.Usage residues were observed on the device.A permanent bend was observed in the guidewire at the exit site from the needle.An attempt to withdraw the guidewire was successful.Microscopic inspection of the distal end of the catheter revealed it was flared outward.The proximal edge of the needle bevel was observed to be rigged and uneven.The bend in the guidewire and catheter deformation were consistent with attempted insertion at a steep angle or insertion against resistance.The biological residue suggested the damage occurred during attempted device placement.This complaint will be recorded for future trending and monitoring purposes.
Event or Problem Description
It was reported via medwatch, "i had a powerglide that had the guidewire stick after it was engaged.I followed the needle tip all the way in.The needle encasement did come apart during insertion.I engaged the guidewire without difficulty.I attempted to advance the catheter and it would not move at all.I then attempted to pull the guidewire back in and it would not move.I removed the unit as (b)(4) piece." additional info 07/30/2024: patient had to be stuck an additional time since this product malfunctioned and insertion had to be aborted.Additional information received via medwatch: "inserting powerglide for intravenous access.During insertion, the housing device came apart and had to be put back together.I advanced the catheter as far as i could, utilizing the ultrasound machine, engaged the guidewire and was unable to advance the catheter from the device.I attempted to withdraw the guidewire from the vein but it was locked in place.Removed entire powerglide as one unit." 09/12/2024 - the device returned for evaluation exhibited a bend in the guidewire.

• Brand Name: FULL KIT 20G X 8 CM WITH PROBE COVER
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 20409839
• Report Number: 3006260740-2024-05787
• Device Sequence Number: 18122743
• Product Code: FOZ
• UDI-Device Identifier: 00801741140624
• UDI-Public: (01)00801741140624(11)231218(17)241231(10)REHX1118
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K162377
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/19/2024

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 Expiration Date: 12/31/2024
• Device Model Number: N/A
• Device Catalogue Number: F220088PT
• Device Lot Number: REHX1118
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2024
• Initial Report FDA Received Date: 10/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2023
• 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: 67 YR
• Patient Sex: Female
• Patient Weight: 151 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White