MAUDE Adverse Event Report: BARD BRACHYTHERAPY, INC. -1424526 I125 SEEDS IN QUICKLINK, STERILE, 11.0 MBQ; BRACHYTHERAPY SEEDS

Catalog Number 1251QCS1

Device Problems Device Contamination with Chemical or Other Material (2944); Packaging Problem (3007)

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

Event Date 07/13/2022

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was not provided, a review of the device history records could not be performed.The return of the sample is pending.However; photos were provided for review.The investigation of the reported event is currently underway.Device pending return.

Event Description

It was reported that prior to a brachytherapy procedure, there was something like small black dust on the sponge part of the seed storage inside the seed package.There was no patient contact.

Manufacturer Narrative

H10: manufacturing review: a device history record review was performed for the affected lot number.The lot met all release criteria.No issues were noted.Investigation summary: the sample (shield foam insert (upper and lower)) along with the pewter shield was returned for evaluation.Black loose particle/fragment/dust was present into the upper shield foam insert.However this particle was into the shield foam insert, not on or in contact with the device and does not affect the device performance.The shield foam insert is part of the packaging inside the pewter shield.The quicklink cartridges are placed within the lower shield foam insert and covered with the upper shield foam insert inside the pewter shield.The investigation is confirmed for the reported issues.A definitive root cause could not be determined based upon available information.Labeling review: labeling was reviewed and found to be adequate.There is a caution statement, which states "do not use if the package is damaged" and that the product was sterile.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 : see h10.

Event Description

It was reported that prior to a brachytherapy procedure, there was something like small black dust on the sponge part of the seed storage inside the seed package.There was no patient contact.

• Brand Name: I125 SEEDS IN QUICKLINK, STERILE, 11.0 MBQ
• Type of Device: BRACHYTHERAPY SEEDS
• 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: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 15182073
• MDR Text Key: 302934860
• Report Number: 1018233-2022-06119
• 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: 09/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1251QCS1
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Sex: Male