MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPORT MRI ISP W/O SUTURE PLUGS, 9.6 FR SILICONE SL CATHETER; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number	1809661
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Fluid/Blood Leak (1250); Fracture (1260); Material Separation (1562); Obstruction of Flow (2423); Failure to Advance (2524); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.However, photos were provided for review.The investigation of the reported event is currently underway.(expiry date: 07/2024).Section a through f - the information provided by bd represents all of 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 that during a port placement procedure, when tried to remove the inner sheath part of the luer-lock piece that is attached to the outer grey sheath allegedly broke off and blood allegedly started to shoot out.It was further reported that the guide wire was allegedly did not enter through the outer sheath and it allegedly occluded.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one 10.0fr peel-apart sheath and one vessel dilator was returned for evaluation and two electronic photos were provided for review.Gross visual and functional testing were performed.The investigation is confirmed for the reported fracture, material separation and identified deformation due to compressive stress and loss of or failure to bond as one detached valve cap was received, the other half of the valve cap was still attached to the t-handle, bunching was noted throughout the peel-apart sheath and the photo review and manufacturing review also confirms the same.However, the investigation is inconclusive for the reported failure to advance, fluid leak and obstruction of flow, as the exact circumstances at the time of reported event was unknown.The definitive root cause could not be determined based upon the available information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: d4 (expiration date: 07/2024).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.H3 other text : see h10.
Event or Problem Description
It was reported that during a port placement procedure, when tried to remove the inner sheath part of the luer-lock piece that is attached to the outer grey sheath allegedly broke off and blood allegedly started to shoot out.It was further reported that the guide wire was allegedly did not enter through the outer sheath and it allegedly occluded.There was no reported patient injury.

• Brand Name: POWERPORT MRI ISP W/O SUTURE PLUGS, 9.6 FR SILICONE SL CATHETER
• 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: 17039749
• Report Number: 3006260740-2023-02195
• Device Sequence Number: 6459110
• Product Code: LJT
• UDI-Device Identifier: 00801741027161
• UDI-Public: (01)00801741027161
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K073423
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2023

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 Model Number: 1809661
• Device Catalogue Number: 1809661
• Device Lot Number: REGY2426
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/08/2023
• Supplement Date Received by Manufacturer: 11/06/2023
• Initial Report FDA Received Date: 06/01/2023
• Supplement Report FDA Received Date: 11/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/11/2023
• 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 Age: 67 YR
• Patient Sex: Female
• Patient Weight: 90 KG
• Patient Race: White