MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC® PROVENA1M CATHETER, 4F DL 3CG; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/29/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported via medwatch "picc line placed on patient's left arm when completed, the inner wire removed and this rn assessed for patency before dressing was completely secured.It was assessed that the red lumen was occluded and purple lumen was flushing well with positive blood return.This rn used 1st wire to assess red lumen by inserting it into red lumen occlusion was noted and felt like something stuck into catheter.Picc line removed and new one placed using sterile cath exchange technique.Upon assessing previous picc the inner wire was noted to be missing end copper tip part.Picc line feels like wire jammed into catheter.Md notified of findings for possible wire fragmentation.Chest x-ray ordered.Chest x-ray did not show anything concerning picc line and wire placed into biohazard bag and placed into iv team manager's box.".
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of reft4476 showed no other similar product complaint(s) from this lot number.

• Brand Name: POWERPICC® PROVENA1M CATHETER, 4F DL 3CG
• 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: 13806591
• Report Number: 3006260740-2022-00844
• Device Sequence Number: 2201361
• Product Code: LJS
• UDI-Device Identifier: 00801741184932
• UDI-Public: (01)00801741184932
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K180548
• 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
• Report Date (Section B): 03/04/2022

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 Model Number: N/A
• Device Catalogue Number: CK000898
• Device Lot Number: REFT4476
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/28/2022
• Initial Report FDA Received Date: 03/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2021
• 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