MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC SOLO CATHETER 4F RADIOLOGY BASIC TRAY (SL) (70 CM NITINOL GUIDEWIRE); CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS

Catalog Number	3194355
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Swelling/ Edema (4577)
Date of Event	10/13/2024
Type of Reportable Event	Serious Injury
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 device has not been returned to the manufacturer for evaluation.
Event or Problem Description
It was reported by customer that the patient originally had peripherally inserted central catheter (picc) line placed for use with intravenous (iv) antibiotic infusion.Patient was discharged from the hospital at that time.The patient was then re-admitted one month later and the picc site was noted to be swollen.Doctor orders were placed to remove the picc line and send the tip for culture.During the removal, the nurse documented that there was no resistance or difficulty felt when removing the line.But what was found was that only a portion of the picc line came out.The doctor was immediately notified, and a chest and arm x-ray was obtained along with an ultrasound of the arm to verify that the retained piece is still in the arm.The patient was taken to interventional radiology (ir) and the retained piece was removed.No other information provided, at this time.
Additional Manufacturer Narrative
Nitial medwatch report was submitted, upon further review it was found that this medwatch report 3006260740-2024-07380 is a duplicate file and has been voided.The original event was submitted on medwatch report 3006260740-2024-06498.
Event or Problem Description
It was reported by customer that the patient originally had peripherally inserted central catheter (picc) line placed for use with intravenous (iv) antibiotic infusion.Patient was discharged from the hospital at that time.The patient was then re-admitted one month later and the picc site was noted to be swollen.Doctor orders were placed to remove the picc line and send the tip for culture.During the removal, the nurse documented that there was no resistance or difficulty felt when removing the line.But what was found was that only a portion of the picc line came out.The doctor was immediately notified, and a chest and arm x-ray was obtained along with an ultrasound of the arm to verify that the retained piece is still in the arm.The patient was taken to interventional radiology (ir) and the retained piece was removed.No other information provided, at this time.

• Brand Name: POWERPICC SOLO CATHETER 4F RADIOLOGY BASIC TRAY (SL) (70 CM NITINOL GUIDEWIRE)
• 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: shelly gilbert ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 20905224
• Report Number: 3006260740-2024-07380
• Device Sequence Number: 3969520
• Product Code: LJS
• UDI-Device Identifier: 00801741027789
• UDI-Public: (01)00801741027789
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K072230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 3194355
• 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: 11/15/2024
• Supplement Date Received by Manufacturer: 12/23/2024
• Initial Report FDA Received Date: 12/11/2024
• Supplement Report FDA Received Date: 01/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Required Intervention
• Patient Age: 49 YR
• Patient Sex: Unknown