MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC SOLO2 3CG 5F DL; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	CK000045A
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and is pending evaluation.Results are expected soon.A lot history review (lhr) of 19lbt943 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported customer reports intravenous fluid leaked from hole in extension leg on red port of dual lumen solo power picc.Leak was noticed upon flushing lumen to confirm patency during insertion procedure.Picc was immediately removed and retained by customer and a new picc was inserted using guidewire exchange.
Event or Problem Description
It was reported customer reports intravenous fluid leaked from hole in extension leg on red port of dual lumen solo power picc.Leak was noticed upon flushing lumen to confirm patency during insertion procedure.Picc was immediately removed and retained by customer and a new picc was inserted using guidewire exchange.
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, trend analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a leaking catheter was confirmed.The product returned for evaluation was one 5fr d/l powerpicc solo catheter.Light usage residues were observed throughout the sample.An attempt to infuse water through the sample using a 12ml syringe revealed the sample to be patent to infusion; however, when flushing the red-luered lumen, a spraying leak was observed emanating from a split site near the luer adapter.Microscopic inspection of the split site revealed two parallel diagonally aligned splits.The splits exhibited sharply defined fracture features.The fracture surfaces exhibited material flow and coarse striations.Surface abrasion was observed in the vicinity of the splits.Diagonally aligned impressions were observed circumferentially opposite the splits.The split characteristics, surface abrasion and opposite impressions were consistent with damage caused by contact between the extension tube and a traumatic grasping instrument, such as forceps or hemostats.The use residues suggested that contact likely occurred as a result of device manipulation during or following device placement.The product ifu states ¿avoid accidental device contact with sharp instruments and mechanical damage to the catheter material.Use only smooth-edged atraumatic clamps or forceps.¿ h3 other text: evaluation findings are in section h11.

• Brand Name: POWERPICC SOLO2 3CG 5F DL
• 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: 10907310
• Report Number: 3006260740-2020-20691
• Device Sequence Number: 13589741
• Product Code: LJS
• UDI-Device Identifier: 00801741087134
• UDI-Public: (01)00801741087134
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K091324
• 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): 12/09/2020

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: CK000045A
• Device Catalogue Number: CK000045A
• Device Lot Number: 19LBT943
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2020
• Initial Date Received by Manufacturer: 11/03/2020
• Supplement Date Received by Manufacturer: 02/11/2021
• Initial Report FDA Received Date: 11/25/2020
• Supplement Report FDA Received Date: 03/12/2021
• 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