MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC 4F SL MAX BARRIER PLUS KIT W/BIOPATCH; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2024
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 manufacturer has received the sample and is pending evaluation.Results are expected soon.
Event or Problem Description
It was reported by the customer "when seasoned nurse was placing a picc, she had one of the orange wings break off on the introducer instead of peeling away." no patient harm was done, another kit was opened and used.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.The complaint of a broken microintroducer handle is confirmed but the exact cause was unknown.Four photographs of a 4 fr single lumen powerpicc were returned for evaluation.An initial visual observation of the photographs showed a catheter inserted into the sheath of a 4.5 fr microintroducer.A portion of the handle of the microintroducer sheath was observed to be completely detached and the proximal end of the grey sheath was left protruding from the other portion of the handle.No pieces of the sheath could be seen in the broken off portion of the handle and what appears to be a small slit was observed in the broken handle piece where the sheath may have been attached.The investigation was forwarded to the manufacturing facility for further evaluation; however, the root cause of the break in the t-handle could not be determined based off evaluation of the returned photographs and without return of a physical sample.This complaint will be recorded for future trending and monitoring purposes.
Event or Problem Description
It was reported by the customer "when seasoned nurse was placing a picc, she had one of the orange wings break off on the introducer instead of peeling away." no patient harm was done, another kit was opened and used.No other information was provided.

• Brand Name: POWERPICC 4F SL 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: kayla bevins ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 19087848
• Report Number: 3006260740-2024-01646
• Device Sequence Number: 15366482
• Product Code: LJS
• UDI-Device Identifier: 00801741155147
• UDI-Public: (01)00801741155147
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K070996
• 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): 07/11/2024

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: 03/31/2025
• Device Model Number: N/A
• Device Catalogue Number: 1174108D5
• Device Lot Number: REHY1891
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2024
• Supplement Date Received by Manufacturer: 07/11/2024
• Initial Report FDA Received Date: 04/11/2024
• Supplement Report FDA Received Date: 07/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2023
• 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