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

Catalog Number	7711804
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	07/17/2025
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 was performed.The sample was not returned to the manufacturer for inspection / evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.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
A patient underwent a port placement procedure using the groshong s/l catheters.Post the procedure catheter was removed for a patient with age and comorbidities.After removal procedure, on the following day the patient returned complaining of chest pain radiating down left shoulder/arm.The patient was discharged.Later surgeon identified while checking mr that the retained fragment that consist with the distal groshong catheter tip containing the embedded reinforcing wire still present in the patient.The current status of the patient was unknown.
Event or Problem Description
A patient underwent a port placement procedure using the groshong s/l catheters.Post the procedure, a catheter was removed for a patient with age and comorbidities.After the removal procedure, on the following day, the patient returned complaining of chest pain radiating down his left shoulder/arm.The patient was discharged.Later, the surgeon identified while checking mr, that the retained fragment that consists of the distal groshong catheter tip containing the embedded reinforcing wire was still present in the patient.
Additional Manufacturer Narrative
H11: manufacturing review: the device history records have been reviewed, and this lot met all release criteria.Investigation summary: one catheter stylet segment was returned for evaluation.Visual evaluations were performed on the returned device.The catheter stylet hub was noted to be missing from the proximal end.The segment was noted to be bent throughout.The edges of the proximal end of the stylet were noted to be jagged, and the nature of separation was noted to be straight indicating that the catheter was trimmed when the stylet was still inside the catheter which is against instructions for use.Therefore, the investigation is inconclusive.The root cause was traced to be use related.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.G3, h6 (method).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: 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: 22783363
• Report Number: 3006260740-2025-05726
• Device Sequence Number: 9869626
• 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: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K831386
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2025

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?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2025
• Supplement Date Received by Manufacturer: 12/11/2025
• Initial Report FDA Received Date: 08/12/2025
• Supplement Report FDA Received Date: 12/15/2025
• 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 Sex: Female