MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC PROVENA 5F TL MAX BARRIER PLUS KIT W/BIOPATCH & PROBE COVER; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Unable to Obtain Readings (1516)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, applicable previous investigation(s), sample analysis, applicable fmea documents, applicable manufacturing records, and labeling.Based on a review of this information, the following was concluded: the complaint of an intermittent signal with the 3cg stylet is inconclusive due to poor sample condition.One 3cg stylet t-lock assembly was returned for evaluation.The grey fin connector and electrodes were not returned.A kink in the polyimide tubing was noted 5.5 cm from the distal tip.The event description does not indicate any deformation to be present and may have occurred during return of the device.A multimeter was used in order to test the continuity of the white fin and distal tip of the stylet.The electrical signal was found to be continuous.The electrical resistance was measured and found to be within manufacturing specification.Based on the information and sample provided, possible contributing factors include damaged grey fin connector or loose connections.Since no apparent issues were noted with the continuity of the stylet, the complaint could not be confirmed and the cause remains inconclusive at this time.A lot history review (lhr) of refn0850 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported "nurse feels as though there is a short in the 3cg wire.While inserting the wire would intermittently pick up and she realized that if she held the 3cg wire a certain way and kept it off from resting on the bed then it would work." (b)(6) 2021: the returned sample exhibited a kink.

• Brand Name: POWERPICC PROVENA 5F TL MAX BARRIER PLUS KIT W/BIOPATCH & PROBE COVER
• 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: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 12786884
• Report Number: 3006260740-2021-04735
• Device Sequence Number: 5094885
• Product Code: LJS
• UDI-Device Identifier: 00801741155079
• UDI-Public: (01)00801741155079
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K053501
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/20/2021

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: S1385108D4
• Device Lot Number: REFN0850
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/18/2021
• Initial Report FDA Received Date: 11/10/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2021
• 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