MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 PPICC SOLO 5F DL FT 3CG; CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS

Catalog Number	CK001028
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	10/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that microintroducer would not advance.No other information was provided.A specific number of affected devices or patients was not provided by the complainant.
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 manufacturer has received the sample and is pending evaluation.A supplemental will be submitted with evaluation results.
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 difficult microintroducer insertion was inconclusive.The product returned for evaluation was one 5fr microintroducer.A gross visual inspection of the returned unit found that both the dilator and sheath were slightly bent midway along the sheath length.Additionally, use residue was present near the sheath tip.However, no other damage was observed throughout the unit.The unit was microscopically inspected but no remarkable features were identified.Given that no damage was identified and no further testing could be performed, no further conclusions could be drawn regarding the reported event.This complaint will be recorded for future trending and monitoring purposes.
Event or Problem Description
It was reported that microintroducer would not advance.No other information was provided.A specific number of affected devices or patients was not provided by the complainant.

• Brand Name: PPICC 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: shelly gilbert ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 20724661
• Report Number: 3006260740-2024-06745
• Device Sequence Number: 3850391
• Product Code: LJS
• UDI-Device Identifier: 00801741223938
• UDI-Public: (01)00801741223938(11)240806(17)251031(10)REJS4788
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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,Followup
• Report Date (Section B): 02/13/2025

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: 10/31/2025
• Device Catalogue Number: CK001028
• Device Lot Number: REJS4788
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2024
• Supplement Date Received by Manufacturer: 02/13/2025
• Initial Report FDA Received Date: 11/19/2024
• Supplement Report FDA Received Date: 03/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2024
• 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