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

Model Number	N/A
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	04/03/2023
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.The manufacturer has received the sample and is pending evaluation.Results are expected soon.
Event or Problem Description
It was reported by the customer that the introducer will not slide in as expected, causing trauma to the skin and vessel because of force needed to insert the device.No additional patient information is available, there were no serious adverse events, but it did cause patient discomfort and delay in treatment time.
Event or Problem Description
It was reported by the customer that the introducer will not slide in as expected, causing trauma to the skin and vessel because of force needed to insert the device.No additional patient information is available, there were no serious adverse events, but it did cause patient discomfort and delay in treatment time.Additional information received: there was no treatment needed for the skin or vessel trauma.
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 difficult insertion is confirmed but the exact cause remains unknown.One 5 fr x 7 cm microez microintroducer was returned for evaluation.A product label indicating lot: regz0186.Dried blood residue and evidence of use was noted on the device.The dilator was present within the sheath which had not been peeled.The distal end of the dilator was observed to be bent.Additional deformation was noted at the sheath tip.Microscopic inspection of the sheath deformation revealed a section of the tip to be bunched inwards.Evidence of the sheath tip taper being present was observed.Based on the information provided, possible contributing factors include advancement against resistance, inadequate skin nick, and sheath tip transition.A review of the manufacturing records did not reveal evidence to suggest a manufacturing related root cause.The damage present on the grey sheath is indicative of a difficult insertion; therefore, the complaint is confirmed but the exact contributing factors remain unknown.

• Brand Name: POWERPICC SOLO
• 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: 16762934
• Report Number: 3006260740-2023-01398
• Device Sequence Number: 2920665
• Product Code: LJS
• UDI-Device Identifier: 00801741223938
• UDI-Public: (01)00801741223938
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: UNK
• 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): 06/19/2023

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: 04/30/2024
• Device Model Number: N/A
• Device Catalogue Number: CK001028
• Device Lot Number: REGZ0186
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/04/2023
• Supplement Date Received by Manufacturer: 06/19/2023
• Initial Report FDA Received Date: 04/18/2023
• Supplement Report FDA Received Date: 06/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2022
• 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