MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC PROVENA CATHETER W/ SOLO VALVE SHERLOCK 3CG (TPS) STYLET (5F) (TL); CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Component Incompatible (1108)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	07/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that introducer has malformation on the gray part and does not allow wire to thread.Add info received on (b)(6) 2023.Directly involve patient, the introducer wouldn¿t thread into patient because of the burr on the end of it.The attempts made to thread introducer failed and trauma in trying to use it as we normally would may have caused some damage and i¿m sure increased the risk of dvt.We were able to drop a introducer kit onto sterile field and use a new introducer which thread easily into patient and allowed us to finish his picc line insertion at bedside.
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.
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
It was reported that introducer has malformation on the gray part and does not allow wire to thread.Add info received on 21-jul-2023.Directly involve patient, the introducer wouldn¿t thread into patient because of the burr on the end of it.The attempts made to thread introducer failed and trauma in trying to use it as we normally would may have caused some damage and i¿m sure increased the risk of dvt.We were able to drop a introducer kit onto sterile field and use a new introducer which thread easily into patient and allowed us to finish his picc line insertion at bedside.

• Brand Name: POWERPICC PROVENA CATHETER W/ SOLO VALVE SHERLOCK 3CG (TPS) STYLET (5F) (TL)
• 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: 17492759
• Report Number: 3006260740-2023-03428
• Device Sequence Number: 7246718
• Product Code: LJS
• UDI-Device Identifier: 00801741112751
• UDI-Public: (01)00801741112751
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K072230
• 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): 09/12/2023

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: 05/31/2024
• Device Model Number: N/A
• Device Catalogue Number: S1395108D
• Device Lot Number: REHQ3506
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2023
• Supplement Date Received by Manufacturer: 09/12/2023
• Initial Report FDA Received Date: 08/09/2023
• Supplement Report FDA Received Date: 09/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2023
• 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: 34 YR
• Patient Sex: Male
• Patient Weight: 86 KG
• Patient Ethnicity: Non Hispanic