MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC 3F SL SOLO MAX BARRIER PLUS KIT W/BIOPATCH; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2020
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 reev2204 showed one other similar product complaint(s) from this lot number.The complaints for this lot number (reev2204) have been reported from the same facility.
Event or Problem Description
It was reported "we are having so much trouble with 3 fr single lumen piccs.It has been off the accuracy with the sherlock several times (perfect ecg graphics, but upper svc or brachiocephalic vein in chest x-rays)." it was stated this occurred twice.This report addresses the first event.
Additional Manufacturer Narrative
H11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.The following were reviewed as part of this investigation: patient severity, complaint and batch history, applicable previous investigation(s), labeling, applicable manufacturing records, sample analysis and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of inaccurate 3cg assisted placement is inconclusive due to poor sample condition.One 3 fr powerpicc solo catheter was provided for evaluation.The 3cg stylet t-lock assembly was returned within the catheter.The catheter extended past the 54 cm depth marker and did not appear to have been trimmed.The 3cg stylet was removed from the catheter and was found to be intact.A slight curve was observed in the polyimide tubing; however, no kinks were present.The continuity of the 3cg stylet was tested from the white fin pin and the distal tip of the wire.The signal was found to be continuous.The resistance was measured and found to be within manufacturing specification.No apparent issues were noted on the returned sample.Based on the description of the reported event, possible contributing factors include improper connections, product interference, clinical conditions.Since the reported issue could not be replicated during functional testing, the complaint remains inconclusive at this time.H3 other text : evaluation findings are in section h.11.
Event or Problem Description
It was reported "we are having so much trouble with 3 fr single lumen piccs.It has been off the accuracy with the sherlock several times (perfect ecg graphics, but upper svc or brachiocephalic vein in chest x-rays)." it was stated this occurred twice.This report addresses the first event.

• Brand Name: POWERPICC 3F SL SOLO MAX BARRIER PLUS KIT W/BIOPATCH
• 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: 11125044
• Report Number: 3006260740-2020-21201
• Device Sequence Number: 3606959
• Product Code: LJS
• UDI-Device Identifier: 00801741155185
• UDI-Public: (01)00801741155185
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K180548
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2021

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: S1193108D5
• Device Lot Number: REEV2204
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2021
• Initial Date Received by Manufacturer: 12/10/2020
• Supplement Date Received by Manufacturer: 04/10/2021
• Initial Report FDA Received Date: 01/06/2021
• Supplement Report FDA Received Date: 05/07/2021
• 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