MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 Titanium Low-Profile Implantable Port, Broviac Single-Lumen, 6.6F; Port & Catheter, Implanted, subcutaneous, Intravascular

Catalog Number	0606100
Medical Device Problem Codes	Entrapment of Device (1212); Fracture (1260); Device Appears to Trigger Rejection (1524); Difficult to Remove (1528); Material Separation (1562); Migration (4003)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Embolism/Embolus (4438); Thrombosis/Thrombus (4440); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported through litigation process that sometime after port placement procedure, the port catheter fractured.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: the physical device was not returned for evaluation.No medical records were provided for review.Therefore, the investigation is inconclusive for the reported catheter fracture as no objective evidence was provided for review.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.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.
Event or Problem Description
It was reported through the litigation process that, on (b)(6) 2018, a patient underwent port placement via the right subclavian vein for carcinoma of right breast.Approximately one year, and three months later, on (b)(6) 2019, the catheter had allegedly fractured with a fragment migrated to right pulmonary artery.A subsequent chest x ray demonstrated the presence of a foreign body in the right middle lobe pulmonary artery.Approximately one month and seventeen days later, on (b)(6) 2019, it was observed that the catheter tip had broken off and lodged in the right pulmonary artery.On the same day, an attempt was made to retrieve the embolized catheter fragment.Additionally, the fragment appeared to be encased in thrombus, preventing retrieval despite multiple attempts.However, the current status of the patient remains unknown.
Additional Manufacturer Narrative
H11: additional information was received, and the file was reassessed for reportability and determined to be reportable as serious injury.As the lot number for the device was provided, a review of the device history records is currently being performed.The device has not been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.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.

• Brand Name: Titanium Low-Profile Implantable Port, Broviac Single-Lumen, 6.6F
• 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: michael gaffney ; 800 w. rio salado pkwy; tempe, AZ 85281 ; +1(480)303-2689
• MDR Report Key: 22148033
• Report Number: 3006260740-2025-03658
• Device Sequence Number: 20951888
• Product Code: LJT
• UDI-Device Identifier: 00801741026041
• UDI-Public: (01)00801741026041(17)220731(10)REBV1513
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K050310
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2026

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2022
• Device Catalogue Number: 0606100
• Device Lot Number: REBV1513
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2025
• Supplement Date Received by Manufacturer: 09/11/2026
• Initial Report FDA Received Date: 06/05/2025
• Supplement Report FDA Received Date: 09/24/2026
• 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: 50 YR
• Patient Sex: Female