MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPORT ISP IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, 6F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number	1706061
Medical Device Problem Codes	Difficult to Flush (1251); Suction Problem (2170); Migration (4003)
Health Effect - Clinical Codes	Insufficient Information (4580); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/02/2021
Type of Reportable Event	Death
Event or Problem Description
It was reported through the litigation process that sometime post a port placement, the port was allegedly non-functional.It was further reported that the port was removed, and new port has been placed.Reportedly, the patient was expired, and the cause of death was not provided.
Additional Manufacturer Narrative
H10: date of death for this patient was not provided, date of death updated as 01-jan-1900 for the mdr submission requirement.H10: 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.H10: d4 (expiry date: 08/2020).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.
Additional Manufacturer Narrative
H10: date of death for this patient was not provided, date of death updated as (b)(6) 1900 for the mdr submission requirement.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: the physical device was not returned for evaluation.No photos were provided for review.However, a medical record was provided for review.Based on this medical record, the difficult to flush, suction problem and catheter migration can be confirmed.However, the medical records did not contain information on the patient death, and no death certificate was provided.Therefore, the investigation is inconclusive for the reported patient death.The definitive root cause for the difficult to flush, suction problem and catheter migration could not be determined based upon the available information.The relationship between the device and reported patient death is unknown.The medical records do not contain definitive reasoning that the alleged patient death was related to the device.Therefore, based upon the available information, the definitive root cause for the event is unknown.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: h6 (device, method).H11: d4 (unique identifier (udi) #), h6 (patient, result, conclusion).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 four days post a port placement, the port was allegedly non-functional.It was further reported that the port had allegedly migrated.Reportedly, the port was removed and replaced.Evidently, the patient was expired, and primary cause of death was not provided, and the relationship of death with the device was not provided.

• Brand Name: POWERPORT ISP IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, 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: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 19379049
• Report Number: 3006260740-2024-02553
• Device Sequence Number: 7619870
• Product Code: LJT
• UDI-Device Identifier: 00801741026553
• UDI-Public: (01)00801741026553(11)181124(17)200831(10)RECX1669
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K072549
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other,Consumer,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2024

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: 08/31/2020
• Device Catalogue Number: 1706061
• Device Lot Number: RECX1669
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/25/2024
• Supplement Date Received by Manufacturer: 09/18/2024
• Initial Report FDA Received Date: 05/23/2024
• Supplement Report FDA Received Date: 09/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/24/2018
• 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: Death
• Patient Age: 69 YR
• Patient Sex: Female