MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC 5F DUAL-LUMEN POLYURETHANE CATHETER RADIOLOGY BASIC TRAY; 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	10/15/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of refy1208 showed no other similar product complaint(s) from this lot number.Device not returned.
Event or Problem Description
It was reported that guidewire provided in the picc set is too flimsy which makes it hard for insertion.As dr was trying to push in, the soft tip (tungsten) broke off from the stainless steel guidewire.Patient status/ intervention: patient is safe and not injured.
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 following were reviewed as part of this investigation: patient severity, complaint and lot history review, applicable previous investigation(s), sample analysis, applicable manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a frayed guidewire is confirmed and was determined to likely be related to the guidewire being pulled against a needle bevel.One 5 fr d/l powerpicc catheter and one 135 cm stainless steel ir guidewire were returned for evaluation.An initial visual observation showed a complete break in the returned guidewire.The distal fragment of guidewire was returned with the coil wire elongated.Use residues were observed along the guidewire.A microscopic observation revealed that both the coil and the core wire were broken, however the weld tip remained attached to the distal fragment of the guidewire.Several bends were observed within the coil region of the guidewire.The core wire appeared detached from the weld tip, and the coil wire was elongated.The coil was not elongated at the proximal fracture site of the core wire.The proximal core wire tip exhibited a tapered break profile, and the break surface appeared polished.Based on observations of the break site such as a tapered break profile, a polished fracture surface edge, and many bends in the vicinity of the break site, the complaint of a frayed guidewire appears to be confirmed and likely due to resistance against the guidewire.Possible contributing factors could include the insertion technique, or the guidewire being retracted through the needle.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.The ifu cautions, ¿if the guidewire must be withdrawn while the needle is inserted, remove both the needle and wire as a unit to prevent the needle from damaging or shearing on the guidewire." h3 other text : evaluation findings are in section h.11.
Event or Problem Description
It was reported that guidewire provided in the picc set is too flimsy which makes it hard for insertion.As dr was trying to push in, the soft tip (tungsten) broke off from the stainless steel guidewire.Patient status/ intervention: patient is safe and not injured.

• Brand Name: POWERPICC 5F DUAL-LUMEN POLYURETHANE CATHETER RADIOLOGY BASIC TRAY
• 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: becky garcia ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 15712507
• Report Number: 3006260740-2022-04246
• Device Sequence Number: 4932313
• Product Code: LJS
• UDI-Device Identifier: 00801741027925
• UDI-Public: (01)00801741027925
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K051672
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2023

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: 02/28/2026
• Device Model Number: N/A
• Device Catalogue Number: 3275135
• Device Lot Number: REFY1208
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/17/2022
• Supplement Date Received by Manufacturer: 01/20/2023
• Initial Report FDA Received Date: 11/01/2022
• Supplement Report FDA Received Date: 01/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2021
• 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 Sex: Unknown