MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC CATHETER 5F MAXIMAL BARRIER TRAY WITH MICROINTRODUCER; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer the picc was used for aquadex pediatric patient and placed in the ij.This line dwelled in the patient from (b)(6) 2023-(b)(6) 2024.The line was discontinued after the patient's status improved and no longer needed aquadex.The suture wings cracked off.They were able to re-suture the picc and use it for another 2 months.The treatment was completed and the line was discontinued on (b)(6) 2024.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 damaged catheter is confirmed; however, the exact cause is unknown.Two photographs of a 5 fr powerpicc catheter were returned for evaluation.An initial visual observation of the photographs showed a catheter inserted in and sutured to a patient.Multiple cracks/tears were observed in the material of the molded joint; however, no details or distinguishing features of the break sites could be seen in the returned photographs which could aid in identification of a specific root cause.Additionally, other unknown factors such as exposure to incompatible chemicals and cleaning/maintenance techniques may have contributed to the observed damage.This complaint will be recorded for future trending and monitoring purposes.H3 other text : evaluation findings are in section h.11.
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 the picc was used for aquadex pediatric patient and placed in the ij.This line dwelled in the patient from (b)(6) 2023-(b)(6) 2024.The line was discontinued after the patient's status improved and no longer needed aquadex.The suture wings cracked off.They were able to re-suture the picc and use it for another 2 months.The treatment was completed and the line was discontinued on (b)(6) 2024.No other information was provided.

• Brand Name: POWERPICC CATHETER 5F MAXIMAL BARRIER TRAY WITH MICROINTRODUCER
• 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: 19091921
• Report Number: 3006260740-2024-01675
• Device Sequence Number: 20745960
• Product Code: LJS
• UDI-Device Identifier: 00801741027871
• UDI-Public: (01)00801741027871
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K051672
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2024

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: 04/30/2024
• Device Model Number: N/A
• Device Catalogue Number: 3275108D
• Device Lot Number: REGY0411
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2024
• Supplement Date Received by Manufacturer: 05/13/2024
• Initial Report FDA Received Date: 04/11/2024
• Supplement Report FDA Received Date: 05/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2022
• 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