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

Model Number	N/A
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported catheter inserted into the right upper arm of a patient with brain disease one month ago.Prior to use, there was resistance to injection, and we received a report that the extension swelled when saline was injected, and we confirmed its patency.The same phenomenon was confirmed when 10cc of prefilled saline was poured into the lumen.Red lumen.There was no blockage in the white lumen, so it was removed after the intended antibiotic administration was completed.A blood clot had formed in the lumen about 7cm from the inside of the valve.Swelling of the extension tube.No other information was provided.
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 device has not been received by the manufacturer for evaluation.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.
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 an extension tubing aneurysm is confirmed and was determined to be use-related.One 5 fr d/l groshong nxt catheter was returned for evaluation.An initial visual observation of the returned catheter slight discoloration observed along the extension tubing of the red lumen.A tactile evaluation of the red extension tubing revealed some tensile weakness along the extension tubing.A tactile evaluation of the white extension tubing revealed no obvious tensile weakness along the extension tubing.A functional test of attempting to infuse water into each lumen using a 12 ml syringe revealed no occlusion through either lumen of the device.A functional test of pressurizing each lumen with water using a 12 ml syringe revealed a catheter aneurysm along the extension tubing of the red lumen.The white lumen extension tubing did not have any catheter aneurysms and was patent to infusion.A microscopic observation revealed longitudinal marks along the extension tubing at the aneurysm location indicating material deformation.Necking was observed at the aneurysm location along the extension tubing when a slight pulling force was applied to the extension tubing.The ifu states, ¿catheters that present resistance to flushing and aspiration may be partially or completely occluded.Do not flush against resistance.If the lumen will neither flush nor aspirate and it has been determined that the catheter is occluded with blood, a declotting procedure per institution protocol may be appropriate.¿ this complaint will be recorded for future trending and monitoring purposes.

• Brand Name: GROSHONG
• 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: 23584792
• Report Number: 3006260740-2025-08762
• Device Sequence Number: 9398339
• Product Code: LJS
• UDI-Device Identifier: 00801741035449
• UDI-Public: (01)00801741035449
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K023374
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2026

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: 7957505
• 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: 10/30/2025
• Supplement Date Received by Manufacturer: 01/13/2026
• Initial Report FDA Received Date: 11/18/2025
• Supplement Report FDA Received Date: 01/14/2026
• 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