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

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2021
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 reey0902 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported "per nursing staff, picc lumens were caught in bed rail and upon repositioning, one lumen was ripped off.Someone applied hemostats to the open ended picc.Iv team assessed the picc and suggested md place central line and picc be removed." additional info.Received 03/23/2021: what type of catheter securement was utilized? adhesive securement device provided in picc kit; secureport iv tissue adhesive; sorbaview securement dressing.

• Brand Name: POWERPICC SOLO PROVENA CATHETER WITH SHERLOCK 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
• MDR Report Key: 11670963
• Report Number: 3006260740-2021-01322
• Device Sequence Number: 19582959
• Product Code: LJS
• UDI-Device Identifier: 00801741201042
• UDI-Public: (01)00801741201042
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K053501
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 04/01/2021

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: CK000410A
• Device Lot Number: REEY0902
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/22/2021
• Initial Report FDA Received Date: 04/15/2021
• 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
• Patient Age: 64 YR
• Patient Weight: 114