MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC CATHETER 6F BASIC TRAY (DUAL-LUMEN) (55CM); CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER 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	11/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported after insertion of the needle, the guidewire was passed.When attempting to remove it, the guide failed (broken).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 manufacturer has received the sample and will evaluate.Results are expected soon.
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.
Event or Problem Description
It was reported after insertion of the needle, the guidewire was passed.When attempting to remove it, the guide failed (broken).No other information was provided.Additional information received 12/16/2023: "device was replaced by another material from the same batch.Problem occur during the procedure.Problem identified in the teflon fabric of the guide wire, guide wire with exposed area of the wire core.".
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 a broken guidewire was confirmed.The product returned for evaluation was one guidewire.The investigation findings are consistent with damage caused by retraction of the guidewire against the bevel of the introducer needle.The returned product sample was evaluated and the guidewire was confirmed to be broken which allowed the outer coil wire to become unraveled.Microscopic examination of the fracture sites revealed the following: ¿ shearing of the wire at the break which was indicative of direct contact with a hard-edged instrument (such as an introducer needle).¿ narrowing of the wire cross-section near the fracture site, which is a characteristic feature of a strong pull on the wire.Normal movement of the guidewire is away from the sharpened bevel and will not damage the wire.If the guidewire direction is reversed, the guidewire is then pulled against the sharpened edge of the needle bevel and can cause shearing damage of the wire and/or cause the wire to become stuck within the needle.An examination of the wire structure revealed no potential damage/defect related to manufacture of the product.".
Event or Problem Description
It was reported after insertion of the needle, the guidewire was passed.When attempting to remove it, the guide failed (broken).No other information was provided.Additional information received 12/16/2023: "device was replaced by another material from the same batch.Problem occur during the procedure.Problem identified in the teflon fabric of the guide wire, guide wire with exposed area of the wire core.".

• Brand Name: POWERPICC CATHETER 6F BASIC TRAY (DUAL-LUMEN) (55CM)
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER 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: 18311153
• Report Number: 3006260740-2023-05645
• Device Sequence Number: 6718028
• Product Code: LJS
• UDI-Device Identifier: 00801741027994
• UDI-Public: (01)00801741027994
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K050931
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/26/2024

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: 11/30/2024
• Device Model Number: N/A
• Device Catalogue Number: 3276118
• Device Lot Number: REFZ3548
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/28/2023
• Supplement Date Received by Manufacturer: 12/16/2023; 02/26/2024
• Initial Report FDA Received Date: 12/12/2023
• Supplement Report FDA Received Date: 01/11/2024; 03/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2021
• 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: 80 YR
• Patient Sex: Male