MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 GROSHONG 8F SINGLE-LUMEN CV CATHETER; CHRONIC CATHETERS

Catalog Number	7711804
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Material Separation (1562); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2025
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 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 using groshong s/l catheter.During the preparation of a chronic catheter placement procedure, the cuff of the groshong catheter had allegedly come off while tunneling.This all occurred outside of the patient.Catheter malfunctioned.The procedure was completed using another device.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 groshong cvc 8fr s/l catheter segment was returned for evaluation.Visual and microscopic evaluations were performed on the returned device.The proximal portion of the catheter was not returned.The tissue cuff was not returned.What appeared to be tissue cuff adhesive residue, was noted between the 23cm depth mark and 25cm depth mark.The manufacturing site review states, visual inspection of the images showed one groshong cvc 8fr s/l catheter segment as the only component to be evaluated, it was observed that the cuff was not present in the catheter body instead there was a residue of adhesive, the cuff was not visible in the images, residues of use were observed throughout the sample.Therefore, the investigation is confirmed for the reported cuff failure to bond and material separation issues.The cause of this condition is related to be manufacturing.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) #), 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 using groshong s/l catheter.During the preparation of a chronic catheter placement procedure, the cuff of the groshong catheter had allegedly come off while tunneling.This all-occurred outside of the patient.Catheter malfunctioned.The procedure was completed using another device.There was no patient contact.

• Brand Name: GROSHONG 8F SINGLE-LUMEN CV CATHETER
• 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: 22307057
• Report Number: 3006260740-2025-04174
• Device Sequence Number: 20817563
• Product Code: LJS
• UDI-Device Identifier: 00801741036767
• UDI-Public: (01)00801741036767(11)250109(17)280630(10)REJY0657
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K831386
• 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: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2025

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: 7711804
• Device Lot Number: REJY0657
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2025
• Supplement Date Received by Manufacturer: 12/08/2025
• Initial Report FDA Received Date: 06/23/2025
• Supplement Report FDA Received Date: 12/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/09/2025
• 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 Age: 54 YR
• Patient Sex: Male