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

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/30/2024
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 will be evaluated.A supplemental will be submitted with evaluation results.
Event or Problem Description
Rn reported the following: line was placed on (b)(6) 2024.Rn charted the 6 cm external was left out.Securacath was used for securement.Patient was getting out patient infusion done and his wife was flushing the line at home.Dressing changes were also done at the facilities' infusion clinic.The patients last abx treatment was 2 weeks ago, so the line was just getting flushed daily.Today, the patient returned to the clinic reporting that for the last few days they have noticed leaking under the dressing.No leaking was noted during abx treatments at the infusion clinic.When the infusion staff assessed the site, they noticed 5 cm external and that leaking was confirmed after flushing.The line was removed due to the patient not needing the picc anymore.Staff reported a fracture at the 2 cm mark.Staff also noted that the securacath was clamped and in place proximal to the fracture/hole.No harm to the patient.No other information was provided.
Event or Problem Description
Rn reported the following: line was placed on (b)(6) 2024.Rn charted the 6 cm external was left out.Securacath was used for securement.Patient was getting out patient infusion done and his wife was flushing the line at home.Dressing changes were also done at the facilitie's infusion clinic.The patients last abx treatment was 2 weeks ago, so the line was just getting flushed daily.Today, the patient returned to the clinic reporting that for the last few days they have noticed leaking under the dressing.No leaking was noted during abx treatments at the infusion clinic.When the infusion staff assessed the site, they noticed 5 cm external and that leaking was confirmed after flushing.The line was removed due to the patient not needing the picc anymore.Staff reported a fracture at the 2 cm mark.Staff also noted that the securacath was clamped and in place proximal to the fracture/hole.No harm to the patient.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.Five photographs of a powerpicc were returned for evaluation.An initial visual observation of the photographs showed that there was a split in the catheter tubing.There were no distinguishing features in the returned photographs of the device which could aid in identification of a specific root cause.This complaint will be recorded for future trending and monitoring purposes.

• Brand Name: POWERPICC SOLO 4F SL MAX BARRIER PLUS KIT W/BIOPATCH, PROBE COVER
• 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: maddy vincent ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 21212306
• Report Number: 3006260740-2025-00081
• Device Sequence Number: 8070480
• Product Code: LJS
• UDI-Device Identifier: 00801741155192
• UDI-Public: (01)00801741155192(11)240603(17)250831(10)REJR1268
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K072230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2025

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: 08/31/2025
• Device Model Number: N/A
• Device Catalogue Number: 1194108D5
• Device Lot Number: REJR1268
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/30/2024
• Supplement Date Received by Manufacturer: 02/11/2025
• Initial Report FDA Received Date: 01/22/2025
• Supplement Report FDA Received Date: 02/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2024
• 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