MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERLINE CV CATHETER, POLYURETHANE SINGLE-LUMEN, 5F; CHRONIC CATHETERS

Catalog Number	0700515
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: as the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.H11: section a through f ¿ the information provided by bd represents all 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.
Event or Problem Description
It was reported that during preparation of a chronic catheter placement procedure, the device was allegedly did not make it into the patient because there was no cuff.There was no patient contact.
Event or Problem Description
It was reported that during preparation of a chronic catheter placement procedure, the device was allegedly did not make it into the patient because there was no cuff.There was no patient contact.
Additional Manufacturer Narrative
H11: manufacturing review: the device history records have been reviewed, and this lot met all release criteria.Investigation summary: one 5f power line s/l catheter loaded onto a tunneler was returned for evaluation.Visual, microscopic, tactile and functional evaluations were performed.The tissue cuff was noted to be missing from the catheter body and was not returned.The tissue cuff was not returned.Adhesive residue was noted near the 4.0cm depth mark.The manufacturing site review states, visual inspection of the images showed a 5f power line s/l catheter, it was observed that the tissue cuff was not present in the catheter body.A closer view revealed the presence of adhesive apparently between the 4.0 cm depth mark, residue from the cuff was also observed in the catheter tube.Therefore, the investigation is confirmed for the reported cuff failure to bond and component missing issues.The definitive root cause could not be determined based upon available information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.D4 (unique identifier (udi) #), g3, h3, h6 (device, component, method, result, conclusion) section a through f ¿ the information provided by bd represents all 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.

• Brand Name: POWERLINE CV CATHETER, POLYURETHANE SINGLE-LUMEN, 5F
• Common Device Name: CHRONIC CATHETERS
• 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: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 21871354
• Report Number: 3006260740-2025-02451
• Device Sequence Number: 18300613
• Product Code: LJS
• UDI-Device Identifier: 00801741036583
• UDI-Public: (01)00801741036583(11)240926(17)280531(10)REJV1545
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: K050185
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/02/2025

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 Catalogue Number: 0700515
• Device Lot Number: REJV1545
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2025
• Supplement Date Received by Manufacturer: 07/25/2025
• Initial Report FDA Received Date: 04/21/2025
• Supplement Report FDA Received Date: 07/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/26/2024
• 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
• Patient Sex: Unknown