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

Catalog Number UNKNOWN PORT

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

Patient Problem Insufficient Information (4580)

Event Date 08/25/2022

Event Type  Injury  

Event Description

The following adverse events were identified in a study 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 other unknown complications reported in 9 patients during the use of the powerport isp m.R.I.Implantable port (unknown product code).Events range in dates from june 17, 2017-july 26, 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 these events is available.

Manufacturer Narrative

As the lot number for the device was not provided, a review of the device history records could not be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.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 Description

This complaint will contain infection events identified in the retrospective multi-centre analysis of bd port implants using mayo clinic ehrs drafted by global clinical affairs for product family powerport isp m.R.I.Implantable port (unknown product code).This report was generated to capture the use of data provided by (b)(6) 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.Events range in dates from june 17, 2017-july 26, 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 these events are available.

Manufacturer Narrative

H10: the event reported in the initial mfr report # 3006260740-2022-03745 was for the reported event of other complications.Following discussion with fda mdr leadership, one mdr will be filed per event; therefore, the event of other complications has been corrected in mfr report #3006260740-2022-04554.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: POWERPORTISP 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 Key: 15480861
• MDR Text Key: 300572197
• Report Number: 3006260740-2022-03745
• Device Sequence Number: 1
• Product Code: LJT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063377
• 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: 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 Number: UNKNOWN PORT
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/25/2022
• Initial Date FDA Received: 09/24/2022
• Supplement Dates Manufacturer Received: 08/25/2022
• Supplement Dates FDA Received: 11/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening