MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 GROSHONG CATHETER; PERIPHERALLY INSERTED CENTRAL CATHETER (PICC)

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11: 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 the manufacturer has received the sample and will be evaluated.A supplemental will be submitted with evaluation results.
Event or Problem Description
It was reported during the patient's initial catheter placement, the catheter fractured externally.With 29 cm retained internally and 6 cm externally exposed, the catheter tip position was confirmed post-insertion.While the nurse was withdrawing the guidewire from the catheter, the catheter fractured completely at the 39 cm mark, 10 cm from the puncture site.The catheter was not immediately removed.After trimming the catheter as standard procedure, it was left in place.The catheter's functionality requires ongoing monitoring.The catheter fractured during insert, specifically when the guidewire was withdrawn after catheter placement; since the fracture occurred beyond the intended clipping site, the catheter remained in the patient's body and continued to be used after clipping.No injury reported.
Additional Manufacturer Narrative
H11: 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.The complaint of a broken catheter is confirmed but the cause is unknown.The returned product was one 3fr groshong catheter with stiffening stylet.A photograph was also submitted by the complainant for review.No additional information was observed in the photograph which changed the conclusion of the investigation.An initial visual observation revealed the stylet was returned inserted in a segment of catheter about 8.4 inches long.Use residue was observed on the sample.A microscopic observation revealed the catheter experienced a break at 39 cm depth mark.The break was observed to have a smooth/granular fracture surface, as well as even and clean edges on the clear side of the catheter.The blue side was observed to have a slightly rough and uneven fracture surface and edges.The catheter was dissected for inspection of the inner wall, and no damage was observed near the break site.The morphology of the damage is consistent with a tensile break; however, the underlying cause could not be determined.This complaint will be recorded for future trending and monitoring purposes.

• Brand Name: GROSHONG CATHETER
• Common Device Name: PERIPHERALLY INSERTED CENTRAL CATHETER (PICC)
• 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: becky sparks ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 23704949
• Report Number: 3006260740-2025-09216
• Device Sequence Number: 18809630
• Product Code: LJS
• UDI-Device Identifier: 00801741087035
• UDI-Public: (01)00801741087035(11)240801(17)270430(10)REJT3329
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K926331
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2026

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 Model Number: N/A
• Device Catalogue Number: 7717305
• Device Lot Number: REJT3329
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2025
• Supplement Date Received by Manufacturer: 01/23/2026
• Initial Report FDA Received Date: 12/03/2025
• Supplement Report FDA Received Date: 01/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown