MAUDE Adverse Event Report: BARD BRACHYTHERAPY, INC. -1424526 IODINE 125 SEEDS IN QUICKLINK , STERILE, 13.1 MBQ; BRACHYTHERAPY LINKS & CARTRIDGES

Catalog Number 1251QCL2

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/02/2021

Event Type  malfunction  

Event Description

It was reported that during a brachytherapy procedure, the device packaging allegedly unsealed.There was no reported patient 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 device has not been returned to the manufacturer for evaluation.However, photos were provided for review.The investigation of the reported event is currently underway.

Manufacturer Narrative

H10: manufacturing review: a device history record review was not performed.The reported product code is not designated with a lot number investigation summary: the sample was not returned to the location.However, photo was provided for review.The photo shows that the tamper evident label was missing on the secondary container d.Based on the evidence, the investigation is confirmed for reported issue and the root cause is manufacturing related.Labeling review: labeling was reviewed and found to be adequate.The information for use was reviewed.There is a caution statement, which states "do not use if the package is damaged" and also "do not re-sterilize".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

It was reported that during a brachytherapy procedure, the device packaging allegedly unsealed.There was no reported patient injury.

• Brand Name: IODINE 125 SEEDS IN QUICKLINK , STERILE, 13.1 MBQ
• Type of Device: BRACHYTHERAPY LINKS & CARTRIDGES
• Manufacturer (Section D): BARD BRACHYTHERAPY, INC. -1424526; 295 east lies road; carol stream 60188
• Manufacturer (Section G): BARD BRACHYTHERAPY, INC. -1424526; 295 east lies road; carol stream 60188
• Manufacturer Contact: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 12880992
• MDR Text Key: 284813140
• Report Number: 1018233-2021-07537
• Device Sequence Number: 1
• Product Code: KXK
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K093663
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/09/2021

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 Catalogue Number: 1251QCL2
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/02/2021
• Initial Date FDA Received: 11/29/2021
• Supplement Dates Manufacturer Received: 12/09/2021
• Supplement Dates FDA Received: 12/13/2021
• 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