MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC PROVENA SOLO 5F DL FT MAX BARRIER PLUS KIT W/BIOPATCH; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Catalog Number	S1295108FD4
Medical Device Problem Codes	Material Deformation (2976); Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/03/2023
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.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 device has not been returned to the manufacturer for evaluation.H3 other text : device not returned for evaluation.
Event or Problem Description
Customer reported that during picc placement the user experienced difficult breaking the introducer sheath when finalizing the placement of a picc.The introducer did not crack cleanly, and the team almost had to completely restart but they were able to break away enough of the introducer to safely remove it and finalize picc placement.No other information was provided.
Event or Problem Description
Customer reported that during picc placement the user experienced difficult breaking the introducer sheath when finalizing the placement of a picc.The introducer did not crack cleanly, and the team almost had to completely restart but they were able to break away enough of the introducer to safely remove it and finalize picc placement.No other information was provided.
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.
Event or Problem Description
Customer reported that during picc placement the user experienced difficult breaking the introducer sheath when finalizing the placement of a picc.The introducer did not crack cleanly, and the team almost had to completely restart but they were able to break away enough of the introducer to safely remove it and finalize picc placement.No other information was provided.
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.Based on a review of this information, the following was concluded: the complaint of difficulty removing the microintroducer sheath was confirmed and appears to be manufacturing related.One 5 fr microez microintroducer sheath was evaluated.The introducer sheath had been fully split and was returned without the dilator.Microscopic inspection of the splitting surface of the handles revealed that the handles did not split evenly along the score line; instead, the break surface was jagged and irregular.One side of the handles contained a ring of material where the orifice into the sheath was located.The intact ring of material may have contributed to difficulty removing the sheath from the catheter.The characteristics seen on the sample appeared to have been caused during the molding process of the t-handle, therefore the cause of this condition is related to manufacturing.This complaint will be recorded for future trending and monitoring purposes.

• Brand Name: POWERPICC PROVENA SOLO 5F DL FT MAX BARRIER PLUS KIT W/BIOPATCH
• 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: suedabba mahboobi ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 17010678
• Report Number: 3006260740-2023-02145
• Device Sequence Number: 7555026
• Product Code: LJS
• UDI-Device Identifier: 00801741155116
• UDI-Public: (01)00801741155116
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K072230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/11/2023

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 Catalogue Number: S1295108FD4
• Device Lot Number: REHN2439
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2023
• Supplement Date Received by Manufacturer: 06/07/2023; 10/10/2023
• Initial Report FDA Received Date: 05/26/2023
• Supplement Report FDA Received Date: 06/16/2023; 10/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2023
• 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 Age: 65 YR
• Patient Sex: Female