MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERLINE CV CATHETER, POLYURETHANE SINGLE-LUMEN, 6F; CHRONIC CATHETERS

Catalog Number	0700610
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Fracture (1260); Material Separation (1562); Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11: 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.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
On (b)(6) 2025, a patient underwent a chronic catheter placement procedure.During the procedure, it was reported that the cuff had allegedly come loose from the powerline.Reportedly, device was opened, upon placement, and noticed that the cuff was loose and it came off.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 6fr powerline d/l catheter in two segments was returned for evaluation.Visual, microscopic, tactile and functional evaluations were performed on the returned device.The sample appeared to have residue throughout.Caps were not noted on both luers.The complaint sample was returned with the clamps engaged.Tissue cuff material was noted to be missing throughout the cuff.What appeared to be adhesive residue, was noted proximal to the tissue cuff on the catheter body.The tissue cuff was noted to move freely throughout the catheter.Lack of adhesive in the tissue cuff area of the catheter was noted.A split was noted on the catheter body approximately 3.7cm from the distal end of the tissue cuff, proximal to the 7.0cm depth mark.The edges of the split on the catheter body were noted to be uneven.The surface could not be determined as additional damage would be caused in area.The manufacturing site review states, it was observed that the tissue cuff was not in its original position, the cuff had shifted slightly, adhesive residues were observed in the cuff area, it was observed that the cuff had been separated from the catheter body, a slight alteration of fibers was observed, residues of use were observed throughout the sample.Therefore, the investigation is confirmed for the reported cuff failure to bond, material separation and identified fracture issue.The definitive root cause could not be determined, based upon available information.Labelling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.B5, d4(unique identifier (udi)), g3, h6 (patient, device, component, method, result, conclusion).Section a through f ¿ the information provide 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
On (b)(6) 2025, a patient underwent a chronic catheter placement procedure.During the procedure, it was reported that the cuff had allegedly come loose from the powerline.Reportedly, device was opened, upon placement, and noticed that the cuff was loose and it came off.There was no reported patient injury.

• Brand Name: POWERLINE CV CATHETER, POLYURETHANE SINGLE-LUMEN, 6F
• 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: 23119807
• Report Number: 3006260740-2025-07112
• Device Sequence Number: 15790732
• Product Code: LJS
• UDI-Device Identifier: 00801741036590
• UDI-Public: (01)00801741036590(11)250513(17)270630(10)REKR0705
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K051417
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2026

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: 0700610
• Device Lot Number: REKR0705
• 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: 08/29/2025
• Supplement Date Received by Manufacturer: 02/10/2026
• Initial Report FDA Received Date: 09/23/2025
• Supplement Report FDA Received Date: 02/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/13/2025
• 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