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

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/21/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported, the patient underwent picc puncture on the morning of (b)(6), and the blood return was smooth and fixed.At about 20:00, the nurse found the infusion pump alarm during the infusion process, checked the patient and found that the catheter was returning to blood, and the catheter near the linker was damaged and leaking, trimmed the extracorporeal catheter and replaced the new catheter connector, and there was no blood return after connection.After the leakage occurred twice, the pruned exposed catheter was used to reconnect the extension tube and continue to use it.There were two reported leaks on the same device.This report addresses both incidences.
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.
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 leak is confirmed; however, the exact cause is unknown.Two photographs of a groshong nxt clearvue catheter and a connector assembly were returned for evaluation.An initial visual observation of the photographs showed an implanted catheter.Small drops of a liquid were observed on the tubing near the insertion site.No details of the leak site could be discerned from the photographs.There were no distinguishing features in the returned photographs of the device which could aid in identification of a specific root cause of the leak.This complaint will be recorded for future trending and monitoring purposes.

• Brand Name: GROSHONG PICC
• 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: 22967565
• Report Number: 3006260740-2025-06606
• Device Sequence Number: 21116594
• Product Code: DQY
• UDI-Device Identifier: 00801741035296
• UDI-Public: (01)00801741035296(11)240523(17)261031(10)REJR1759
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K871080
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 7715405
• Device Lot Number: REJR1759
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2025
• Supplement Date Received by Manufacturer: 09/11/2025
• Initial Report FDA Received Date: 09/04/2025
• Supplement Report FDA Received Date: 09/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/23/2024
• 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: Required Intervention
• Patient Sex: Unknown