MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 FULL KIT 18G X 10 CM WITH GUARDIVA AND PROBE COVER; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/22/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, applicable previous investigation(s), sample analysis, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of guidewire failure to advance was inconclusive due to the condition of the returned sample.The product returned for evaluation was one 18ga x 10cm powerglide pro midline catheter assembly.Usage residues were observed throughout the sample.The catheter had been advanced and the safety mechanism was engaged.The catheter remained attached to the advancer.The catheter exhibited curved shape memory along the proximal half of the catheter shaft.The sample was received partially disassembled.The needle/safety/catheter assembly was completely detached from the housing.The guidewire advancer was loose within the housing and was not engaged with the guidewire.Microscopic inspection of the catheter revealed deformation of the tip.The edges of the catheter tip were buckled and flared outward.Microscopic inspection the guidewire revealed it to be intact.Slight curved shape memory was observed within the coil/core region.Microscopic inspection of the guidewire advancer revealed wear marks within the coupler region.The disassembled condition of the sample upon receipt prevented determination of the state of the guidewire during attempted device use.Consequently this complaint is inconclusive at this time.The wear marks on the coupler region of the guidewire advancer indicated that the wire was initially properly assembled with the advancer.The guidewire and catheter deformation were consistent with resistance encountered during attempted device insertion, which may have contributed to the reported event as guidewire advancement against resistance can cause it to become disengaged from the advancer.A batch history review (bhr) of regu2409 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported by the customer "guidewire did not deploy and was found coiled in the back of the device handle." 02/16/2023 - the returned sample exhibited a damaged catheter tip.

• Brand Name: FULL KIT 18G X 10 CM WITH GUARDIVA AND 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: 16444130
• Report Number: 3006260740-2023-00560
• Device Sequence Number: 5600084
• Product Code: FOZ
• UDI-Device Identifier: 00801741140563
• UDI-Public: (01)00801741140563
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 02/24/2023

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: 09/30/2023
• Device Model Number: N/A
• Device Catalogue Number: F118108PT
• Device Lot Number: REGU2409
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/16/2023
• Initial Report FDA Received Date: 02/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2022
• 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 Sex: Unknown