MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 M.R.I. HARD BASE IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, KIT, 8F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number	0605450
Medical Device Problem Codes	Device Appears to Trigger Rejection (1524); Suction Problem (2170); Obstruction of Flow (2423)
Health Effect - Clinical Codes	Unspecified Infection (1930); Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440); Bacteremia (4846)
Date of Event	10/23/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported through litigation process that sometime post a port placement, the port catheter was allegedly occluded.It was further reported that the patient developed with infection and thrombosis.However, the current status of the patient was unknown.
Additional Manufacturer Narrative
H10: as the lot number for the device was not provided, a review of the device history records could not 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 provide 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) 2015, a patient underwent the port placement on the right chest port for venous access for mantle cell lymphoma.Sometime after the port placement procedure, the patient was diagnosed with bacteremia.It was further reported that, on (b)(6) 2015, a fluoroscopic evaluation revealed presence of thrombus in the port reservoir, along with poor blood return.Additionally, it was reported that the patient was diagnosed with occlusion.Subsequently, the infected port was removed on (b)(6) 2015, and a new port was implanted.However, the current status of the patient remains unknown.
Additional Manufacturer Narrative
H11: 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.B5, d1, d4 (medical device catalog #, medical device lot #, unique identifier (udi) #), g3, g4, h6 (patient, device, result, conclusion).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)2015, a patient underwent the port placement in the right chest for venous access for mantle cell lymphoma.Sometime after the port placement procedure, the patient was diagnosed with bacteremia.It was further reported that, on (b)(6)2015, a fluoroscopic evaluation revealed presence of thrombus in the port reservoir, along with poor blood return.Additionally, it was reported that the patient was diagnosed with occlusion.Subsequently, the infected port was removed on (b)(6)2015, and a new port was implanted.However, the current status of the patient remains unknown.
Additional Manufacturer Narrative
H11: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this lot.Investigation summary: although the physical device was not returned for evaluation, medical record was provided for review.The medical records allege that, medical record alleges that the patient underwent implantation of a bard titanium implantable port for lymphoma treatment.Several months later, the patient developed bacteremia, followed by port malfunction with thrombus formation and poor blood return.One week later, due to infection and device dysfunction, the port was removed, and a new port was implanted.Therefore, it can be confirmed that the patient had experienced infection, thrombosis, suction issues, bacteremia, obstruction of flow and catheter occlusion.However, the relationship to the port is unknown.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.G3, h6 (device, component, method, result, conclusion).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: M.R.I. HARD BASE IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, KIT, 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: michael gaffney ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 20720550
• Report Number: 3006260740-2024-06737
• Device Sequence Number: 17764580
• Product Code: LJT
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K873213
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/01/2026

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 Expiration Date: 05/28/2019
• Device Catalogue Number: 0605450
• Device Lot Number: REZB0158
• 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: 10/23/2024
• Supplement Date Received by Manufacturer: 02/23/2026; 06/23/2026
• Initial Report FDA Received Date: 11/19/2024
• Supplement Report FDA Received Date: 03/19/2026; 07/07/2026
• 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: 65 YR
• Patient Sex: Male