MAUDE Adverse Event Report: BARD BRACHYTHERAPY, INC. -1424526 BARD BRACHYSOURCE I-125 IMPLANT SEEDS IN CARTRIDGES; IODINE LOOSE CARTRIDGE

Model Number PS1251CS

Device Problems Labelling, Instructions for Use or Training Problem (1318); Component Missing (2306)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.The device was not returned.

Event Description

It was reported that the standard assay certificates were missing from the package.

Manufacturer Narrative

This complaint was confirmed, as a manufacturing-related issue.The root cause was the qa technician who reviewed the order, inadvertently omitted the standard measurement certificate from the order.The other affected sales order, only had the duplicate certificate present in release documentation, which indicated the original was most likely sent to the customer.No sample was returned for evaluation.A device history record review as not performed as the reported product code does not have a lot number.The customer order release documentation for the affected sales order numbers were retrieved and reviewed.There were 2 copies of the standard measurement certificates, one original and one duplicate copy.This situation indicated the original copy was not included with the customer's order.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 : the device was not returned.

Event Description

It was reported that the standard assay certificates were missing from the package.

• Brand Name: BARD BRACHYSOURCE I-125 IMPLANT SEEDS IN CARTRIDGES
• Type of Device: IODINE LOOSE CARTRIDGE
• Manufacturer (Section D): BARD BRACHYTHERAPY, INC. -1424526; 295 east lies road; carol stream IL 60188
• MDR Report Key: 8831101
• MDR Text Key: 152571032
• Report Number: 1018233-2019-04240
• Device Sequence Number: 1
• Product Code: KXK
• UDI-Device Identifier: 00801741078224
• UDI-Public: (01)00801741078224
• Combination Product (y/n): N
• PMA/PMN Number: K093663
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 03/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PS1251CS
• Device Catalogue Number: PS1251CS
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/08/2019
• Initial Date FDA Received: 07/26/2019
• Supplement Dates Manufacturer Received: 03/25/2020
• Supplement Dates FDA Received: 04/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1