MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC, 3CG; PERIPHERALLY INSERTED CENTRAL CATHETER (PICC)

Catalog Number	1174108D2
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2025
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.Each event reported to bd is evaluated and investigated in accordance with our complaint investigation procedures.The investigation process includes, but is not limited to, evaluation of the event details provided by the complaint facility, a review of complaint history, manufacturing records and risk document where applicable, and an evaluation of the subject device when available to identify potential contributing factors.The date of event was not provided by the complainant/reporter, the date reflected in this report is the date bd became aware of the event.The device has not been returned to the manufacturer for evaluation.
Event or Problem Description
It was reported "we had a patient that was discharged with a 4fr sl provena and went to a skilled nursing facility.The picc was removed at the facility due to leaking.The patient stated that when the rn flushed the catheter, the picc "leaked fluid" under the dressing.I can only assume this is at/around the hub.The injection caps were apparently replaced, but since it was leaking under the dressing this did not alleviate the issue.The picc was subsequently removed and the patient was readmitted to the hospital where the picc was replaced.There are many unknowns at the point of care with regard to picc care/maintenance at the skilled nursing facility.The facility uses the securacath compression style securement device.The picc team placed a bard 4fr power picc single lumen picc on (b)(6) 2025 for long term iv antibiotics, no complications noted with picc insertion and was used at the facility with no leaking noted.Patient was discharged to skilled nursing facility on (b)(6) 2025 where she continued on the long term iv antibiotics.Patient states that while she was there, her picc line started leaking (possibly at the hub area) as she stated the dressing was getting wet when the nurse flushed the line or gave antibiotics.Per the patient chart the picc was removed on (b)(6) 2025, apparently the course of antibiotics completed (but the picc was still leaking during the course of treatment per the patient).The patient was readmitted to our facility on (b)(6) 2025 (not because of leaky picc but recurring infection).New picc was placed on (b)(6) 2025, no complications noted and picc was used without any issues.Patient sent back to skilled nursing facility on (b)(6) with bard picc.It is unknown how long or when the picc started leaking as this was reported by the patient.Additional information: 1.There was no harm or injury to the patient.However, the negative outcome was that the patient's picc had to be removed due to reported leaking.Again, this information was reported by the patient and was not confirmed by our picc team.It should be noted that the our picc team placed this patient's picc line when she was a patient at our facility.The patient was then discharged to a skilled nursing facility, which is where the apparent leaking of the picc occurred.2.Unfortunately, there were no photos or physical evidence as the picc was discarded.Our picc team was not notified that there was a "leaky" picc.Our team was asked to place a "new" picc when the patient was readmitted to the skilled nursing facility.

• Brand Name: POWERPICC, 3CG
• Common Device Name: PERIPHERALLY INSERTED CENTRAL CATHETER (PICC)
• 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: veronica lee ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 22143963
• Report Number: 3006260740-2025-03636
• Device Sequence Number: 12816083
• Product Code: LJS
• UDI-Device Identifier: 00801741154836
• UDI-Public: (01)00801741154836(11)250225(17)260228(10)REKN2031
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: K070996
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/22/2025

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: 02/28/2026
• Device Catalogue Number: 1174108D2
• Device Lot Number: REKN2031
• 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: 05/19/2025
• Initial Report FDA Received Date: 06/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/25/2025
• 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