MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 TITANIUM IMPLANTABLE PORT, GROSHONG SINGLE-LUMEN VENOUS CATHETER, 8F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number	0602810
Medical Device Problem Codes	Fracture (1260); Difficult to Remove (1528); Material Separation (1562)
Health Effect - Clinical Codes	Extravasation (1842); Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported through litigation process that sometime post port placement procedure, the catheter allegedly fractured.There was no reported patient injury.
Additional Manufacturer Narrative
H10: as the lot number for the device was provided, a review of the device history records will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.H11: 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.
Additional Manufacturer Narrative
H11: additional information was identified in medical records, and the file was reassessed for reportability and determined to be reportable as serious injury.Manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this lot.Investigation summary: the physical device was not returned for evaluation, medical report was provided for review.Medical record alleges that, the patient underwent an implantable port placement procedure using a power port via left subclavian vein for chemotherapy delivery.Fourteen years and ten months and five days later, it was reported that the left subclavian tunneled power infusion port demonstrates leakage of contrast in the left infraclavicular region.No contrast is identified in the central venous system.Fifteen days later, the patient had a replacement port placement procedure performed on the same day via right subclavian vein.An attempt was made to remove the port catheter from left subclavian vein, it would not come out.Gentle traction was applied, but the catheter still would not come out.The port was disconnected, and a wire was placed in the catheter to remove it.Fluoroscopy was used for this attempt.The wire advanced about one third of the way down the catheter but would not progress further.The catheter and the wire were then clamped together with a hemostat, and traction was attempted, but the catheter would not fully come out.As a result, the wire was removed, the excess catheter was removed, and the end of the catheter was tied off.Therefore, the investigation is confirmed for the reported catheter fracture and difficult to remove issues.The investigation is unconfirmed for the reported material separation issue as no evidence was found under fluoroscopy before the removal procedure.Furthermore, the clinical conditions alleged in the complaint can be confirmed.Based upon the available information, the definitive root cause is unknown.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.B1, b3, b5, g3, h1, h6 (patient, device, method, result).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
It was reported through litigation process that, on (b)(6) 2006, a patient underwent port placement via the left subclavian vein for chemotherapy delivery.Approximately fourteen years, ten months and five days later, on (b)(6) 2021, the catheter had allegedly fractured.Additionally, it was reported that contrast leakage was observed in the left infraclavicular region.Subsequently, on (b)(6) 2021, the port was removed.During the removal, multiple attempts to remove the entire catheter were unsuccessful.However, the current status of the patient was unknown.

• Brand Name: TITANIUM IMPLANTABLE PORT, GROSHONG SINGLE-LUMEN VENOUS CATHETER, 8F
• 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: 21270789
• Report Number: 3006260740-2025-00174
• Device Sequence Number: 17122708
• Product Code: LJT
• UDI-Device Identifier: 00801741025693
• UDI-Public: (01)00801741025693(10)REQC0644
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K050310
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2026

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 Catalogue Number: 0602810
• Device Lot Number: REQC0644
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2025
• Supplement Date Received by Manufacturer: 04/15/2026
• Initial Report FDA Received Date: 01/30/2025
• Supplement Report FDA Received Date: 04/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Age: 55 YR
• Patient Sex: Male