MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC SOLO CATHETER 5F RADIOLOGY BASIC TRAY (DUAL-LUMEN); CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of refr2417 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the powerpicc solo catheter was placed smoothly on (b)(6) 2022.But the catheter was found kinked when removed from patient.Patient status/ intervention: no intervention.
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 batch history, applicable previous investigation(s), labeling, applicable manufacturing records, sample analysis and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a kinked guidewire is confirmed.One guidewire was returned for evaluation within its hoop.One photo sample of guidewire within its hoop was also returned.A kink in the distal end of the guidewire was noted and corresponded with the returned physical sample.A kink was noted 5 cm from the distal end.Usage residue was visible on the distal end of the guidewire.The distal weld tip was present and no evidence of a break in the wire was noted.The outer diameter of the guidewire was measured and found to be within manufacturing specification.The event description indicates the kink was noted on the wire after removal from the insertion site.Based on the information provided, likely contributing factors include damage during handling and advancement or retraction against resistance.Since a kink in the wire was observed, the complaint is confirmed.H3 other text : evaluation findings are in section h.11.
Event or Problem Description
It was reported that the powerpicc solo catheter was placed smoothly on 25/03/2022.But the catheter was found kinked when removed from patient.Patient status/ intervention: no intervention.

• Brand Name: POWERPICC SOLO CATHETER 5F RADIOLOGY BASIC TRAY (DUAL-LUMEN)
• 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: kelsey erickson ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 14115676
• Report Number: 3006260740-2022-01284
• Device Sequence Number: 14891929
• Product Code: LJS
• UDI-Device Identifier: 00801741028106
• UDI-Public: (01)00801741028106
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K072230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2022

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 Model Number: N/A
• Device Catalogue Number: 3295135
• Device Lot Number: REFR2417
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/28/2022
• Supplement Date Received by Manufacturer: 06/17/2022
• Initial Report FDA Received Date: 04/14/2022
• Supplement Report FDA Received Date: 06/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2021
• 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: Female