MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC SOLO 5F DL FT 3CG; 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	03/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by customer that nine picc kit introducer had issues with difficult insertion.No other information was provided.09/12/2024: nine 5fr microez microintroducers were returned for evaluation, it was found during an investigation there five of the microintroducers had deformation of the sheath.This report addresses the first device.
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 microintroducer insertion was confirmed and determined to be use related.The products returned for evaluation were nine 5fr microez microintroducers.The returned units were evaluated and deformation of the sheath was observed on all nine devices.The following observations were noted during the sample evaluation: usage residue was seen on all returned units.Damaged at the edges of the sheath was present in units 01, 04, 05, 08, and 09.Buckling of the sheath, which is indicative of compression failure, was observed at the location of bends in the sheath in units 02, 03, 06, and 07.The shape, location, and extent of the damage observed on the returned units suggested that the microintroducer sheaths were most likely damaged due to excessive insertion force, an inadequate skin nick, and/or a steep insertion angle.This complaint will be recorded for future trending and monitoring purposes.

• Brand Name: POWERPICC SOLO 5F DL FT 3CG
• 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: 20430057
• Report Number: 3006260740-2024-05870
• Device Sequence Number: 7608388
• Product Code: LJS
• UDI-Device Identifier: 00801741223938
• UDI-Public: (01)00801741223938(11)231113(17)241231(10)REHX0563
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K091324
• 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
• Report Date (Section B): 09/12/2024

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: 12/31/2024
• Device Model Number: N/A
• Device Catalogue Number: CK001028
• Device Lot Number: REHX0563
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2024
• Initial Report FDA Received Date: 10/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2023
• 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