MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC SOLO2 CATHETER WITH TIP LOCATION SYSTEM (TPS) STYLET; 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	01/05/2021
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 (b)(4) showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported a teenager had a 5f powerpicc solo inserted tuesday (b)(6).It was a difficult insertion and was obstructed at subclavian.Flushing was difficult.Patient continues to have problems when device is flushed/aspirated.Both flush well, when one lumen is aspirated blood is also noticed in other lumen.Picc team have suggested fibrin sheath.Iv infusions have been carried out.(b)(6) 2021: there is a suggestion of communication between the device lumens and some flushing difficulty despite lumen patency.

• Brand Name: POWERPICC SOLO2 CATHETER WITH TIP LOCATION SYSTEM (TPS) STYLET
• 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
• MDR Report Key: 11679316
• Report Number: 3006260740-2021-01374
• Device Sequence Number: 2980881
• Product Code: LJS
• UDI-Device Identifier: 00801741028663
• UDI-Public: (01)00801741028663
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K072230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/29/2021

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: 9295118
• Device Lot Number: REEQ2560
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/24/2021
• Initial Report FDA Received Date: 04/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other