MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 UNKNOWN POWER PORT; IMPLANTABLE PORT

Catalog Number UNKNOWN POWER PORT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hematoma (1884)

Event Date 04/24/2023

Event Type  Injury  

Event Description

The following adverse events were identified in several studies utilizing electronic health record data provided by mayo clinic to bd for the purpose of evaluating clinical outcomes for bard¿ long-term implantable ports (power and non-power) used in a contemporary real-world cohort of patients.This mdr will capture the hematoma reported during the use of the power port m.R.I.Implantable port product (unknown product code).Events range in dates from (b)(6) 2017 - (b)(6) 2022.Potential device-related adverse events were detected using the presence of diagnosis and procedure codes occurring on the date of port-implant or up to the date of a terminal event.To ensure privacy, the data have undergone statistical anonymization to preclude reidentification with high probability.This de-identification process includes all dates and times, which are randomly adjusted.Therefore, any individual procedure, patient or event information is not available.No part or lot numbers are available, and no devices were returned for evaluation at the time of the study.No additional information regarding these events is available.

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 samples were not returned to the manufacturer for inspection/evaluation.Therefore, the investigations of the reported events are inconclusive.Based upon the available information, the definitive root cause for these events is unknown.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.H11: 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.H3 other text: device not returned.

Event Description

The following adverse events were identified in several studies utilizing electronic health record data provided by mayo clinic to bd for the purpose of evaluating clinical outcomes for bard¿ long-term implantable ports (power and non-power) used in a contemporary real-world cohort of patients.This mdr will capture the hematoma reported during the use of the power port m.R.I.Implantable port product (unknown product code).Events range in dates from june 17, 2017-may 11, 2022.Potential device-related adverse events were detected using the presence of diagnosis and procedure codes occurring on the date of port-implant or up to the date of a terminal event.To ensure privacy, the data have undergone statistical anonymization to preclude reidentification with high probability.This de-identification process includes all dates and times, which are randomly adjusted.Therefore, any individual procedure, patient or event information is not available.No part or lot numbers are available, and no devices were returned for evaluation at the time of the study.No additional information regarding these events is available.

Manufacturer Narrative

H10: manufacturing review: a manufacturing review was not requested as the lot number reported as unknown.Investigation summary: the physical device was not returned for evaluation.No photos were provided for review.Therefore, the investigation is inconclusive for the reported failure as no objective evidence was provided for review.Furthermore, clinical events reported in the complaint cannot be confirmed.The definitive root cause could not be determined based upon available information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H11: d1, g4, h6 (conclusion).H11: 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.

• Brand Name: UNKNOWN POWER PORT
• Type of Device: IMPLANTABLE PORT
• 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: 16974476
• MDR Text Key: 315827641
• Report Number: 3006260740-2023-02019
• Device Sequence Number: 1
• Product Code: LJT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/19/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN POWER PORT
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/24/2023
• Initial Date FDA Received: 05/22/2023
• Supplement Dates Manufacturer Received: 05/23/2023
• Supplement Dates FDA Received: 06/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening