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

Model Number	N/A
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2023
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 by the customer that the guide wire frayed upon removal.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 damaged powerglide pro guidewires was confirmed and the cause appeared to be use-related.The product returned for evaluation was two 18ga x 10cm powerglide pro midline catheters.Usage residues were observed throughout both samples.The first sample exhibited a complete break in the core wire.The coil wire was intact.The elongated wire was caught within the catheter, which had been advanced off the needle.The safety mechanism was engaged and fully covered the needle tip.The needle shaft was bent.The second sample exhibited complete breaks in both the core and coil wires.A fragment of elongated coil wire was received completely removed from the coil wire.The distal most fragment of wire, including the weld tip was not returned.The catheter was advanced and the safety mechanism was engaged and fully covered the needle tip.The needle shaft was bent.Microscopic inspection of both core wire fractures revealed granular fracture surfaces with regions of increased luster.Inspection of both needle bevels revealed deformation along the proximal edges.Inspection of the catheters revealed buckling at the distal tips.The guidewire fracture features and needle bevel deformation were consistent with damage caused by contact between the guidewires and the introducer needle tips.Such contact can occur if the guidewire is withdrawn against the needle at a sharp angle.The catheter tip deformation and bent introducer needles further suggested that initial insertion against resistance may have contributed.
Event or Problem Description
It was reported by the customer that the guide wire frayed upon removal.No other information was provided.04/12/2024 - two devices were returned for evaluation.The returned devices exhibited breaks in the guidewire.This report addresses the first device.

• Brand Name: BASIC KIT 18G X 10 CM WITH BIOPATCH
• 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: kayla bevins ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 18103467
• Report Number: 3006260740-2023-05083
• Device Sequence Number: 17643206
• Product Code: FOZ
• UDI-Device Identifier: 00801741140518
• UDI-Public: (01)00801741140518
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 04/12/2024

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: 08/31/2024
• Device Model Number: N/A
• Device Catalogue Number: F318107T
• Device Lot Number: REHS3974
• 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: 10/23/2023
• Supplement Date Received by Manufacturer: 04/12/2024
• Initial Report FDA Received Date: 11/09/2023
• Supplement Report FDA Received Date: 04/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2023
• 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