MAUDE Adverse Event Report: I125 SEEDS AND SOURCELINK IN THE READYLINK CONFIGURATION, STERILE, 11.0 MBQ; BRACHYTHERAPY LINKS AND CARTRIDGES

Catalog Number 1251RL1

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 12/25/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that during a procedure, white stain was allegedly noted on the plastic packaging.There was no reported patient injury.

Manufacturer Narrative

H10: manufacturing review: there were no other similar complaint for the given product and trending code(s) reported within the period of review.As this product code is not designated with a lot number, this information is not applicable for the history review.Investigation summary: based on evaluation of the actual sample, this complaint is confirmed.The root cause is packaging-related and occurs during package sealing.There is a transfer of some of the tyvek glue from the tyvek lid onto the retainer lid when the package is sealed and is inherent in the process.There is no introduction of foreign material or change in packaging materials.The product was contained within the pewter shield and did not come in contact with the glue.Labeling review: the information for use that accompanied this customer order was reviewed.There is a caution statement, which states "do not use if the package is damaged" and that the product was sterile.H10: g3.H11: h6(method, result, conclusion).H11: section a through f ¿ the information provide by bd represents all 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 during a procedure, white stain was allegedly noted on the plastic packaging.There was no reported patient injury.

Manufacturer Narrative

H10: the fda rn number for the mdr mfr report no was inadvertently submitted as 2020394.The correct fda rn number was (b)(4).H10: manufacturing review: there were no other similar complaint for the given product and trending code(s) reported within the period of review.As this product code is not designated with a lot number, this information is not applicable for the history review.Investigation summary: based on evaluation of the actual sample, this complaint is confirmed.The root cause is packaging-related and occurs during package sealing.There is a transfer of some of the tyvek glue from the tyvek lid onto the retainer lid when the package is sealed and is inherent in the process.There is no introduction of foreign material or change in packaging materials.The product was contained within the pewter shield and did not come in contact with the glue.Based upon the available information a definitive root cause could not be determined.Labeling review: the information for use that accompanied this customer order was reviewed.There is a caution statement, which states "do not use if the package is damaged" and that the product was sterile.H10: g3.H11: section a through f ¿ the information provide by bd represents all 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 during a procedure, white stain was allegedly noted on the plastic packaging.There was no reported patient injury.

• Brand Name: I125 SEEDS AND SOURCELINK IN THE READYLINK CONFIGURATION, STERILE, 11.0 MBQ
• Type of Device: BRACHYTHERAPY LINKS AND CARTRIDGES
• MDR Report Key: 11213721
• MDR Text Key: 228167774
• Report Number: 2020394-2020-21107
• Device Sequence Number: 1
• Product Code: KXK
• Combination Product (y/n): N
• PMA/PMN Number: K991280
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 05/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1251RL1
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2021
• Date Manufacturer Received: 04/15/2021
• 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 Outcome(s): Other