MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC FT CATHETER 5F RADIOLOGY BASIC TRAY DL (70CM NITINOL GUIDEWIRE); CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 device has not been returned to the manufacturer for evaluation.
Event or Problem Description
It was reported by the customer that "picc placed on (b)(6) 2023 for daily infusion.Noted leak at purple port on (b)(6) 2023 picc line removed.Midline placed to complete treatment.No patient harm.".
Event or Problem Description
It was reported by the customer that "picc placed 2/15/23 for daily infusion.Noted leak at purple port on (b)(6) 2023 picc line removed.Midline placed to complete treatment.No patient harm." additional information received 03/28/2023: 1) did the event occur during an urgent or life-threatening medical situation? if yes, please provide details.No 2) did the event result in a clinically significant delay in therapy that caused a negative outcome for the patient? no.
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 manufacturer has received the sample and is pending evaluation.Results are expected soon.
Event or Problem Description
It was reported by the customer that "picc placed (b)(6) 2023 for daily infusion.Noted leak at purple port on (b)(6) 2023 picc line removed.Midline placed to complete treatment.No patient harm." additional information received 03/28/2023: 1) did the event occur during an urgent or life-threatening medical situation? if yes, please provide details.No 2) did the event result in a clinically significant delay in therapy that caused a negative outcome for the patient? no.
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 complaint of a leak was confirmed.The product returned for evaluation was one 5 fr dual lumen powerpicc catheter.The investigation findings are consistent with catheter damage caused by contact with a sharp-edged instrument such as a scalpel or scissors.The returned product sample was evaluated, and a relatively large, angular split was observed in the extension leg tubing of the purple lumen about 2 cm proximal to the molded joint.Microscopic examination of the split confirmed characteristics of contact with a sharp bladed instrument, and the features observed which supported this type of failure included: ¿ the fracture surfaces were reflective in nature and contained a striated pattern.This can occur due to pattern transfer of the ground-sharpened edge typically found on a scalpel-type instrument.¿ distinctly formed fracture edges ¿ planar shape to the fracture surfaces an examination of the catheter structure revealed no potential damage/defect related to manufacture of the product.H3 other text : evaluation findings are in section h.11.

• Brand Name: POWERPICC FT CATHETER 5F RADIOLOGY BASIC TRAY DL (70CM NITINOL GUIDEWIRE)
• 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: 16667780
• Report Number: 3006260740-2023-01131
• Device Sequence Number: 5972770
• Product Code: LJS
• UDI-Device Identifier: 00801741027970
• UDI-Public: (01)00801741027970
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K051672
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/08/2023

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: 3275355F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/15/2023
• Supplement Date Received by Manufacturer: 03/28/2023; 05/08/2023
• Initial Report FDA Received Date: 04/03/2023
• Supplement Report FDA Received Date: 05/01/2023; 05/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Age: 71 YR
• Patient Sex: Female
• Patient Weight: 65 KG