MAUDE Adverse Event Report: BARD BRACHYTHERAPY, INC. IODINE SEED CALIBRATED CE MARK; IODINE BRACHY SEEDS

Catalog Number PS1251KCE

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

Patient Problems Incontinence (1928); Urinary Retention (2119); Urinary Incontinence (4572)

Event Type  Injury  

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.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.

Event Description

It was reported through the results of a market research study, that sometime post radioactive seed implant, problem(s) passing urine and leakage of urine were reported.The current status of the patient(s) was not provided.

Manufacturer Narrative

The fda rn number for the mdr 2020394-2020-05809 was inadvertently submitted as 2020394.The correct fda rn number was 1018233.Manufacturing review: a device history record review could not be performed as the lot number is unknown.Investigation summary: the sample was not returned for evaluation.No other objective evidence was returned for review.Therefore, the investigation is inconclusive for the alleged failure.The definitive root cause for the reported condition of urine leakage / passing of urine could not be determined based upon the provided information.Labeling review: as there was no product malfunction reported by the customer, a labeling review is not applicable.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 Description

It was reported through the results of a market research study, that sometime post radioactive seed implant, problem(s) passing urine and leakage of urine were reported.The current status of the patient(s) was not provided.

• Brand Name: IODINE SEED CALIBRATED CE MARK
• Type of Device: IODINE BRACHY SEEDS
• Manufacturer (Section D): BARD BRACHYTHERAPY, INC.; 295 east lies road; carol stream IL 60188
• MDR Report Key: 10585284
• MDR Text Key: 208496134
• Report Number: 2020394-2020-05809
• Device Sequence Number: 1
• Product Code: KXK
• Combination Product (y/n): N
• PMA/PMN Number: K093663
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,study
• Type of Report: Initial,Followup
• Report Date: 05/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PS1251KCE
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other