MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC 4F SL MAX BARRIER PLUS W/GUARDIVA, PROBE COVER & BELDAR NEEDLE GUIDES; 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	04/11/2024
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 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.H3 other text : device not returned for evaluation.
Event or Problem Description
It was reported by customer that the patient noticed leaking from the connection between the end of the lumen and needless connector.We placed the picc without issue, but shortly after, the patient noticed leaking from the connection between the end of the lumen and needless connector.We ended up catching it very early and were able to exchange the picc.However, patient was scheduled for chemo later in the day.Once we removed the picc, it was clear that we were unable to get a sealed connection between the needless connector and end of the red lumen.We tried multiple needless connectors, all with the same outcome.Fluid would slowly leak around the red lumen.

• Brand Name: POWERPICC 4F SL MAX BARRIER PLUS W/GUARDIVA, PROBE COVER & BELDAR NEEDLE GUIDES
• 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: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 19226087
• Report Number: 3006260740-2024-01993
• Device Sequence Number: 12666553
• Product Code: LJS
• UDI-Device Identifier: 00801741154935
• UDI-Public: (01)00801741154935
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K070996
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/16/2024

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 Model Number: N/A
• Device Catalogue Number: 1174108D3
• Device Lot Number: UNKNOWN
• 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: 04/11/2024
• Initial Report FDA Received Date: 05/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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