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

Catalog Number	0700515
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2024
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 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
It was reported that during the preparation of chronic catheter placement procedure, the cuff allegedly falls off and also cuff allegedly broken and separated.The procedure was completed using another device.There was no reported 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 powerline s/l catheter was returned for evaluation.Visual, microscopic and tactile evaluations were performed on the returned device.The tissue cuff was intact and appeared to have blue discoloration.Under microscopic observation, the tissue cuff appeared glossy and matted.What appeared to be adhesive, was noted on the ends of the tissue cuff.The tissue cuff was noted to move freely throughout the catheter.Lack of adhesive in the tissue cuff area of the catheter was noted.The manufacturing site review states, visual inspection of the images showed a 5fr powerline s/l catheter.A closer view showed adhesive at the ends of the cuff, the cuff was detached from the body of the catheter, the presence of adhesive was observed in the section of the catheter, slight blue spots were observed in the tubing of the catheter just where the cuff was removed.The causes of the blue spots on the catheter cuff are unknown.Therefore, the investigation is confirmed for the reported cuff lack of adhesive, fracture and material separation 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, h4, h6 (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
It was reported that during the preparation of chronic catheter placement procedure; the cuff allegedly falls off and also cuff allegedly broken and separated.The procedure was completed using another device.There was no reported patient contact.

• Brand Name: POWERLINE CV CATHETER, POLYURETHANE SINGLE-LUMEN, 5F
• Common Device Name: CHRONIC CATHETER
• 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: 21046485
• Report Number: 3006260740-2024-07953
• Device Sequence Number: 8409212
• Product Code: LJS
• UDI-Device Identifier: 00801741036583
• UDI-Public: (01)00801741036583(11)240711(17)271130(10)REJS1961
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 01/17/2025

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: REJS1961
• 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: 12/04/2024
• Supplement Date Received by Manufacturer: 07/07/2025
• Initial Report FDA Received Date: 12/31/2024
• Supplement Report FDA Received Date: 07/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/11/2024
• 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