MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 GROSHONG REPAIR KIT

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2026
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.Each event reported to bd is evaluated and investigated in accordance with our complaint investigation procedures.The investigation process includes, but is not limited to, evaluation of the event details provided by the complaint facility, a review of complaint history, manufacturing records and risk document where applicable, and an evaluation of the subject device when available to identify potential contributing factors.The device has not been returned to the manufacturer for evaluation.
Event or Problem Description
It was reported that, a defect on the product piccline groshong, during a therapeutic injection at the connection closest to the patient, the connection was cracked within the tubing and leaked.Picc-line fitted on (b)(6) 2025.The patient had to return to the operating theatre.We had to remove the picc-line and have one fitted again by the anesthetists because it was impossible to fit a vvp to the patient.
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 leaking catheter is confirmed; however, the exact root cause could not be determined.One 4 fr groshong nxt clearvue catheter was returned for evaluation.An initial visual observation revealed the catheter was attached to the two-piece connector and a statlock retainer was clipped to the molded joint.The catheter appeared to have been trimmed distal to the 10 cm depth mark.Splits were observed between the 16cm and 17 cm depth mark and in the extension leg tubing.A yellow residue was observed within the catheter just proximal to the split in the catheter shaft.The residue was physically noted and appeared to be a thick infusate.A functional test of flushing the catheter with water was performed, and a leak was observed from the extension tubing just distal to the white collar.The catheter was noted to be occluded where the thick infusate was located as no water was observed to leak from the split in the catheter shaft or from the distal valve.A microscopic observation revealed the split on the extension tubing was s-shaped and the fracture surface was smooth and granular.The catheter shaft was observed to be slightly twisted and compressed near the split in the catheter shaft, and some superficial damage was noted.The observed damage on the extension leg was likely caused by a burst due to the occlusion noted in the catheter; however, the root cause of the occlusion could not be determined.This complaint will be recorded for future trending and monitoring purposes.

• Brand Name: GROSHONG REPAIR KIT
• Common Device Name: GROSHONG REPAIR KIT
• 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: yolanda thompson ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 24251893
• Report Number: 3006260740-2026-00454
• Device Sequence Number: 9657741
• Product Code: LJS
• UDI-Device Identifier: 00801741075261
• UDI-Public: (01)00801741075261
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: UNKNOWN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2026

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: 7812400CE
• Device Lot Number: UNKNOWN
• 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: 01/21/2026
• Supplement Date Received by Manufacturer: 03/31/2026
• Initial Report FDA Received Date: 02/03/2026
• Supplement Report FDA Received Date: 04/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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