MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC CATHETER (4F) (SINGLE-LUMEN) (55CM); CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Pain (1994); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2023
Type of Reportable Event	Malfunction
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 date of event was not provided by the complainant/reporter, the date reflected in this report is the date bd became aware of the event.The device has not been returned to the manufacturer for evaluation.
Event or Problem Description
It was reported by the customer that pulled a bard picc catheter customer placed with a tear at about the 5cm mark after 1 week of use.No other information was provided.
Event or Problem Description
It was reported by the customer that pulled a bard picc catheter customer placed with a tear at about the 5cm mark after 1 week of use.No other information was provided.Additional info received on 16-june-23: it was reported by the customer "patient is receiving 6 weeks of antibiotics.The event did not involve an urgent or life-threatening medical situation.The catheter tear was discovered upon removal due to leaking and pain at the site of the catheter tear.This caused a delay in treatment for 3 days.Catheter was secured with statlock.Patient required a tunneled ij catheter because peripheral venous depletion.Date of event was 17 days after insertion".
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 damaged catheter was confirmed.The product returned for evaluation was one 4 fr single lumen powerpicc.The investigation findings are consistent with damage accumulated through flexural fatigue.Flexural fatigue occurs due to cyclic kinking of the catheter tube in which physiological, placement, usage, and mechanical factors may gradually form a crack(s) in the catheter.The returned product sample was evaluated and a kink and split were observed in the catheter material between the 5 and 6 cm depth markers.The catheter split contained physical features associated with material fatigue, and the characteristics observed which supported this type of failure included: ¿ kinking damage which was circumferentially aligned ¿ splitting of the catheter material at the corners of the kink ¿ dulling of the surface of the catheter tubing due to repeated material wear ¿ overall elliptical shape to the fracture cross-section (a result of repeated kinking of the tubing) an examination of the catheter structure revealed no potential damage/defect related to manufacture of the product.H3 other text : device not returned for evaluation.

• Brand Name: POWERPICC CATHETER (4F) (SINGLE-LUMEN) (55CM)
• 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: becky garcia ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 17131003
• Report Number: 3006260740-2023-02435
• Device Sequence Number: 6487716
• Product Code: LJS
• UDI-Device Identifier: 00801741144783
• UDI-Public: (01)00801741144783
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K070996
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/01/2023

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 Expiration Date: 03/31/2024
• Device Model Number: N/A
• Device Catalogue Number: CK000796
• Device Lot Number: REGX3288
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2023
• Supplement Date Received by Manufacturer: 09/01/2023
• Initial Report FDA Received Date: 06/14/2023
• Supplement Report FDA Received Date: 09/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2022
• 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: 35 YR
• Patient Sex: Male