MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 FULL KIT 20G X 10 CM WITH 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	08/28/2024
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 device has not been returned to the manufacturer for evaluation.
Event or Problem Description
It was reported, during training on vein block, the wire from power glide was missing after activating safety.Patient was not involved.Wire is not in a person.No other information was provided.
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 difficulty advancing the guidewire was confirmed and the cause was determined to be use related.The product returned for evaluation was a one 20 ga powerglide pro.The returned product sample was evaluated and the guidewire was observed to be disengaged from the coupler region of the advancer, causing the guidewire to remain within the housing during attempted advancement the following observations were noted during the sample evaluation: usage residue was seen on the guidewire which indicated that the product had experienced at least some use guidewire deformation was observed which suggested potential attempted advancement into tissue wear marks were observed on the coupler, which indicated that the guidewire was initially correctly assembled inspection of the guidewire confirmed it to be intact.Attempted advancement of the guidewire against resistance, such as into tissue, may cause the guidewire to become disengaged from the guidewire coupler, causing the guidewire to fail to advance.This complaint will be recorded for future trending and monitoring purposes.
Event or Problem Description
It was reported, during training on vein block, the wire from power glide was missing after activating safety.Patient was not involved.Wire is not in a person.No other information was provided.

• Brand Name: FULL KIT 20G X 10 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: maddy vincent ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 20273211
• Report Number: 3006260740-2024-05383
• Device Sequence Number: 7175291
• Product Code: FOZ
• UDI-Device Identifier: 00801741140631
• UDI-Public: (01)00801741140631(10)REHQ4278
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,Followup
• Report Date (Section B): 10/30/2024

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: 05/31/2024
• Device Model Number: N/A
• Device Catalogue Number: F220108PT
• Device Lot Number: REHQ4278
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2024
• Supplement Date Received by Manufacturer: 10/30/2024
• Initial Report FDA Received Date: 09/20/2024
• Supplement Report FDA Received Date: 11/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2023
• 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 Sex: Unknown