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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPORT M.R.I. IMPLANTABLE PORT

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C.R. BARD, INC. (BASD) -3006260740 POWERPORT M.R.I. IMPLANTABLE PORT Back to Search Results
Catalog Number UNKNOWN POWER PORT
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Arrhythmia (1721)
Event Date 08/25/2022
Event Type  Injury  
Event Description
The following adverse events were identified utilizing electronic health record data provided by mayo clinic to bd for the purpose of evaluating clinical outcomes for bardtm long-term implantable ports (power and non-power) used in a contemporary real-world cohort of patients.This mdr will capture the arrhythmia reported during the use of the powerport m.R.I.Implantable port product (unknown product code).Events range in dates from (b)(6) 2017- (b)(6) 2021.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 this event is available.
 
Manufacturer Narrative
This initial mdr is being submitted post-discussions with fda mdr leadership.The due date for this mdr is (b)(6) 2022.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.
 
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Brand Name
POWERPORT M.R.I. IMPLANTABLE 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 Key15764206
MDR Text Key303393785
Report Number3006260740-2022-04810
Device Sequence Number1
Product Code LJT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K073423
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Study
Reporter Occupation Physician
Type of Report Initial
Report Date 11/09/2022
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
Device Operator Health Professional
Device Catalogue NumberUNKNOWN POWER PORT
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/25/2022
Initial Date FDA Received11/09/2022
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 Number1
Patient Outcome(s) Life Threatening;
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