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	Fracture (1260); Material Separation (1562); Stretched (1601); Improper or Incorrect Procedure or Method (2017); Material Protrusion/Extrusion (2979); Migration (4003)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	07/17/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H11: as the lot number for the device was provided, a review of the device history records was 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
A patient underwent a port placement procedure using the groshong s/l catheters.Post the placement procedure, it was reported that the catheter was removed due to age and comorbidities of patient.A prominence was noted over the right neck.Chest xray revealed a linear opaque structure consistent with retained internal reinforcing wire from the groshong.The patient returned to the or for removal.And it was identified that retained fragment as consistent with the distal groshong catheter tip containing the embedded reinforcing wire.And reflects mechanical separation at the tip-to-body junction.The current status of the patient was unknown.
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 confirmed for the identified improper procedure or method.However, it is inconclusive for the reported migration issues as supporting evidence of the reported migration is not available and unconfirmed for the reported fracture, material separation, stretched and material protrusion or extrusion issues as improper or incorrect procedure or method was identified.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 (device, component, method, result, conclusion).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 placement procedure, it was reported that the catheter was removed due to the age and comorbidities of the patient.A prominence was noted over the right neck.Chest x-ray revealed a linear opaque structure consistent with retained internal reinforcing wire from the groshong.The patient returned to the or for removal.It was identified that the retained fragment was consistent with the distal groshong catheter tip containing the embedded reinforcing wire and reflects mechanical separation at the tip-to-body junction.The current status of the patient was unknown.

• 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: 22782135
• Report Number: 3006260740-2025-05724
• Device Sequence Number: 10045640
• 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?: Yes
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female