MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC 3F SL SOLO MAX BARRIER PLUS KIT W/GUARDIVA; 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	10/31/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer "two microintroducers bent when trying to insert." no other information was provided.This report addresses the first device.On (b)(6) 2023 - the customer reported this event occurred on two devices however only returned one device for evaluation.This file will address the returned microintroducer tip that exhibited a section with inward bunching.
Additional Manufacturer Narrative
The date of event was not provided by the complainant/reporter, the date reflected in this report is the date bd became aware of the event.The following were reviewed as part of this investigation: patient severity, complaint and batch history, applicable previous investigation(s), applicable manufacturing records, sample analysis and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a difficult insertion is confirmed and appears to be manufacturing related.One 3.5 fr x 7 cm microez microintroducer was provided for evaluation.The dilator was present within the sheath and the sheath had not been split.A written note indicated lot: regr1824 was also provided.Deformation at the sheath tip appeared to be present.Microscopic inspection of the tip revealed a section with inward bunching.The tip taper did not appear to be fully formed which created a blunt transition.This tip transition appears to be a likely contributing factor to the resistance experienced during reported insertion procedure.The evaluation conducted by the manufacturing facility concluded that the blunt transition likely occurred during the tipping process; therefore, the complaint is confirmed.Bd is working closely with the manufacturing facility to prevent reoccurrence of the reported event.A batch history review (bhr) of regr1824 showed one other similar product complaint(s) from this lot number.The complaints for this lot number have been reported from the same facility in united states.

• Brand Name: POWERPICC 3F SL SOLO MAX BARRIER PLUS KIT W/GUARDIVA
• 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: 16248339
• Report Number: 3006260740-2023-00136
• Device Sequence Number: 20484372
• Product Code: LJS
• UDI-Device Identifier: 00801741154980
• UDI-Public: (01)00801741154980
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: K180548
• 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): 01/24/2023

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: 05/31/2023
• Device Model Number: N/A
• Device Catalogue Number: S1193108D3
• Device Lot Number: REGR1824
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/20/2023
• Initial Report FDA Received Date: 01/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2022
• 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