MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC SOLO2 CATHETER WITH SHERLOCK 3CG TIP POSITIONING; 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	Swelling/ Edema (4577)
Date of Event	03/31/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer that "picc leaking at insertion site.The nurses stated the arm looked slightly swollen in the morning so they ordered a vascular ultrasound to evaluate for a clot.The ultrasound was negative.The nurse evaluated the patient and felt there may be a break in the picc.Additional information received 4/17/2023: it was reported by the customer "picc was reported to be leaking at site.When further evaluated after discontinuing picc from patient, it was noted to have a break in the picc at 5/6 cm mark.".
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 that "picc leaking at insertion site.The nurses stated the arm looked slightly swollen in the morning so they ordered a vascular ultrasound to evaluate for a clot.The ultrasound was negative.The nurse evaluated the patient and felt there may be a break in the picc.Additional information received on 4/17/2023: it was reported by the customer "picc was reported to be leaking at site.When further evaluated after discontinuing picc from patient, it was noted to have a break in the picc at 5/6 cm mark.".
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.Device not returned for evaluation.

• Brand Name: POWERPICC SOLO2 CATHETER WITH SHERLOCK 3CG TIP POSITIONING
• 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: 16792213
• Report Number: 3006260740-2023-01485
• Device Sequence Number: 5679284
• Product Code: LJS
• UDI-Device Identifier: 00801741154881
• UDI-Public: (01)00801741154881
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K072230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2023

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: 1194108D2
• Device Lot Number: REGT6037
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/01/2023
• Supplement Date Received by Manufacturer: 06/27/2023
• Initial Report FDA Received Date: 04/21/2023
• Supplement Report FDA Received Date: 06/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2022
• 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 Age: 81 YR
• Patient Sex: Female