MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC CATHETER WITH 3CG TIP POSITIONING SYSTEM; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of refv2272 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported by the customer "clinician removed a picc today on a patient and a section of it was ballooned out.It was a single lumen, lot # refv2272, exp (b)(6) 2022, and was placed on (b)(6) 2022.Today the line was exchanged over the wire purely because the patient needed more access than the single lumen.When removed, there was no resistance, it's completely intact, initially she thought it was a fibrin sheath but on closer inspection obviously not.She does have the catheter to inspect it.Total length was 44cm and the ballooned area is between the 35cm and 37cm marks.".
Event or Problem Description
It was reported by the customer "clinician removed a picc today on a patient and a section of it was ballooned out.It was a single lumen, lot # refv2272, exp 10/31/22, and was placed on 5/20/22.Today the line was exchanged over the wire purely because the patient needed more access than the single lumen.When removed, there was no resistance, it's completely intact, initially she thought it was a fibrin sheath but on closer inspection obviously not.She does have the catheter to inspect it.Total length was 44cm and the ballooned area is between the 35cm and 37cm marks.".

• Brand Name: POWERPICC CATHETER WITH 3CG TIP POSITIONING SYSTEM
• 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: kelsey erickson ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 14876027
• Report Number: 3006260740-2022-02480
• Device Sequence Number: 14751134
• Product Code: LJS
• UDI-Device Identifier: 00801741143748
• UDI-Public: (01)00801741143748
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K091324
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2022

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: 10/31/2022
• Device Model Number: N/A
• Device Catalogue Number: CK000631B
• Device Lot Number: REFV2272
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/09/2022
• Supplement Date Received by Manufacturer: 07/18/2022
• Initial Report FDA Received Date: 06/30/2022
• Supplement Report FDA Received Date: 07/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2021
• 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