MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 M.R.I. LOW-PROFILE IMPLANTABLE PORT, GROSHONG SINGLE-LUMEN, 7F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number	0603870
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11: manufacturing review: the device history records have been reviewed, and this lot met all release criteria.Investigation summary: the physical device was not returned for evaluation.However, one video was provided for review.The videos show a clinician holding introducer needle in which the needle hub was connected to external syringe and the needle tip was closed by clinician for testing purpose.The clinician was trying to inject the fluid from external syringe through introducer needle in which fluid leak from the needle hub can be seen.Therefore, the investigation is confirmed for the identified fluid leak issue as the leak noted from needle hub.However, the investigation is unconfirmed for the reported limited information as more specific fluid leak was identified during investigation.A definitive root cause could not be determined based upon the provided information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.Section a through f ¿ the information provided by bd represents all 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.
Event or Problem Description
On (b)(6) 2025, during a port placement procedure, the port allegedly had malfunction of the central venous access port needle of the port.There was no reported patient injury.

• Brand Name: M.R.I. LOW-PROFILE IMPLANTABLE PORT, GROSHONG SINGLE-LUMEN, 7F
• Common Device Name: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• 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: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 22640761
• Report Number: 3006260740-2025-05295
• Device Sequence Number: 12079028
• Product Code: LJT
• UDI-Device Identifier: 00801741025839
• UDI-Public: (01)00801741025839(11)230117(17)270630(10)REGY2416
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K924250
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/04/2025

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 Catalogue Number: 0603870
• Device Lot Number: REGY2416
• 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: 07/03/2025
• Initial Report FDA Received Date: 07/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/17/2023
• 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
• Patient Sex: Unknown