MAUDE Adverse Event Report: C.R. Bard, Inc. (BASD) -3006260740 PowerPort MRI, 9.6 Fr. Silicone, Inter. Kit w/Suture Plug, S/L; Port & Catheter, Implanted, subcutaneous, Intravascular

Catalog Number	1859600
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bruise/Contusion (1754); Hematoma (1884)
Date of Event	01/06/2014
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported through the litigation process that, on (b)(6) 2014, a patient underwent port placement via the right internal jugular vein for the treatment of b cell lymphoma.Approximately two days later, on (b)(6) 2014, the patient experienced bruising at the port site.Additionally, approximately two days later, on (b)(6) 2014, hematoma was observed around the insertion site.Subsequently, the port was removed on (b)(6) 2015.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: the physical device was not returned for evaluation.The medical records allege that, power port m.R.I.Implantable port was implanted in a patient via the right internal jugular vein for the treatment of b cell lymphoma.Two days later skin around the port insertion was bruised.Two days later there was hematoma around the insertion site.Subsequently, one year, two months, twenty five days later the port was removed.Therefore, it can be confirmed that the patient experienced bruise and hematoma.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.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: PowerPort MRI, 9.6 Fr. Silicone, Inter. Kit w/Suture Plug, S/L
• 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: 50067080
• Report Number: 3006260740-2026-05307
• Device Sequence Number: 18762075
• Product Code: LJT
• UDI-Device Identifier: 00801741027208
• UDI-Public: (01)00801741027208(17)150930(10)REXH1915
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K073423
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/15/2026

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: 09/30/2015
• Device Catalogue Number: 1859600
• Device Lot Number: REXH1915
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2026
• Initial Report FDA Received Date: 07/29/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: Atorvastatin; Bifibacterium lactobacillus; Carvedilol; Folid acid; Levothyroxine; Pantoprazole; Prednisone
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR
• Patient Sex: Female
• Patient Weight: 231 LB
• Patient Race: White