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

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	06/19/2025
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.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 the pediatric patient, diagnosed with acute lymphoblastic leukemia, underwent chemotherapy via a picc line.Prior to infusion, the catheter was flushed using a pre-flush catheter.No blood return was observed upon aspiration.However, after drug administration, fluid was detected seeping beneath the adhesive film.Catheter maintenance was performed, during which damage and leakage were identified at the exposed distal end of the catheter.The picc placement nurse was consulted.Following assessment, the damaged section of the catheter was trimmed.Subsequent maintenance revealed no further leakage.
Additional Manufacturer Narrative
Initial medwatch report was submitted, upon further review it was found that this medwatch report 3006260740-2025-10072 is a duplicate file and has been voided.The original event was submitted on medwatch report 3006260740-2025-08877.

• Brand Name: GROSHONG CATHETER
• Common Device Name: PERIPHERALLY INSERTED CENTRAL CATHETER
• 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: 23919148
• Report Number: 3006260740-2025-10072
• Device Sequence Number: 15719292
• Product Code: LJS
• UDI-Device Identifier: 00801741087035
• UDI-Public: (01)00801741087035(11)231001(17)250930(10)REHV0286
• 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: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/30/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2025
• Device Model Number: N/A
• Device Catalogue Number: 7717305
• Device Lot Number: REHV0286
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2025
• Supplement Date Received by Manufacturer: 12/30/2025
• Initial Report FDA Received Date: 12/29/2025
• Supplement Report FDA Received Date: 01/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/01/2023
• 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