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

Model Number	N/A
Medical Device Problem Codes	Break (1069); Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/06/2026
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.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, the patient was admitted to the department of hematology on (b)(6) 2025, for diffuse large b-cell lymphoma, where a picc line was placed for chemotherapy.On (b)(6) 2026, the patient was admitted to the department of gastroenterology due to common bile duct stones.Because the patient was on a fasting regimen due to the stones and required parenteral nutrition, the picc line was used for intravenous infusion.At 6:10 pm on (b)(6) a nurse on rounds noticed that fluid was not dripping from the picc line.Upon inspection, the nurse observed obvious signs of the adhesive tape having been torn, with parts of it detached from the skin.Upon inquiry, it was learned that the patient had felt the adhesive tape was too tight and uncomfortable, so they removed it themselves without notifying the medical staff.This caused the blue extension tube of the picc to break at the connection point due to stress.Examination revealed the main catheter was intact, with no residual segments left in the body.Infusion was immediately stopped, and the proximal end of the picc catheter was clamped.The patient¿s vital signs were assessed as stable, with no local bleeding, swelling, pain, or symptoms of air embolism.A specialized oncology nurse was consulted.Following strict aseptic techniques, the picc line was trimmed, the connector was replaced, and the new connector was securely fastened.The infusion resumed smoothly.Following the procedure, the patient was provided with reinforced health education on picc line maintenance, explicitly prohibiting self-adjustment or tearing of the securing tape.Due to timely detection and proper management, the incident caused no harm to the patient.

• 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: maddy vincent ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 25082445
• Report Number: 3006260740-2026-03139
• Device Sequence Number: 18760215
• Product Code: LJS
• UDI-Device Identifier: 00801741035326
• UDI-Public: (01)00801741035326(11)241119(17)270831(10)REJW3361
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K871998
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2026

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: 7717405
• Device Lot Number: REJW3361
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2026
• Supplement Date Received by Manufacturer: 06/09/2026
• Initial Report FDA Received Date: 05/05/2026
• Supplement Report FDA Received Date: 06/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/19/2024
• 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