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

Catalog Number	0700615
Medical Device Problem Codes	Deformation Due to Compressive Stress (2889); Difficult to Open or Remove Packaging Material (2922)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2025, a patient getting prepared for a central line placement procedure using a powerline central venous catheter.Prior to the procedure, the plastic covering on the tunneller was found to be completely stuck and could not be removed.A new kit has been opened to complete the procedure.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 tunneler with a loaded protective sheath was returned for evaluation.Visual, functional and dimensional evaluations were performed on the returned device.The proximal tip of the tunneler was noted to be bent within the protective sheath.The distal portion of the tunneler appeared to be slightly bent.An attempt to remove the loaded protective sheath from the tunneler was performed and was unsuccessful.The sheath felt stuck on the proximal portion of the tunneler as it was not able to move forward or be pulled back.Another attempt was performed using an in-house cut resistant glove, for a better grip in removing the loaded protective sheath.The attempt was successful as the sheath was removed throughout the proximal portion of the tunneler.The manufacturing evaluation site states, the tunneler could be seen placed on a flat surface, and the tip of the device appeared to be slightly bent.A closer view revealed residues of a transparent material along the body of the tunneler.Therefore, the investigation is confirmed for the reported difficult to open or remove packaging and also for identified tunneler tip deformation 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.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.

• Brand Name: POWERLINE CV CATHETER, POLYURETHANE DUAL-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: 24975879
• Report Number: 3006260740-2026-02779
• Device Sequence Number: 21202356
• Product Code: LJS
• UDI-Device Identifier: 00801741036606
• UDI-Public: (01)00801741036606(11)240621(17)280930(10)REJS1055
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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
• Report Date (Section B): 04/20/2026

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: 0700615
• Device Lot Number: REJS1055
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2026
• Initial Report FDA Received Date: 04/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/21/2024
• 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