MAUDE Adverse Event Report: 18 GA APPLICATOR NEEDLE 5; BRACHYTHERAPY IMPLANT NEEDLES

Model Number	918205
Medical Device Problem Codes	Unsealed Device Packaging (1444); Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history record is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.(expiry date: 02/2023).Device pending return.
Event or Problem Description
It was reported that prior to the procedure, the device package was allegedly opened.There was no patient contact.
Event or Problem Description
It was reported that prior to the procedure, the device package was allegedly in opened state.There was no patient contact.
Additional Manufacturer Narrative
H10: the fda rn number for the mdr 2020394-2021-00816 was inadvertently submitted as 2020394.The correct fda rn number was 1018233.H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the bard brachytherapy needle was returned for evaluation.The components received included cannulas, stylets, with needle protectors; the stylets were returned inserted within the cannulas.The packaging appeared to be open at the proximal end.The device components appeared unaffected.Based on the findings, the investigation is confirmed for the reported packaging issue as the it was noted that the packaging was opened in conditions.A definitive root cause for the reported packaging issue could not be determined based upon the provided information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: d4 (expiry date: 02/2023).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.

• Brand Name: 18 GA APPLICATOR NEEDLE 5
• Common Device Name: BRACHYTHERAPY IMPLANT NEEDLES
• MDR Report Key: 11627188
• Report Number: 2020394-2021-00814
• Device Sequence Number: 3667986
• Product Code: IWJ
• UDI-Device Identifier: 10801741075961
• UDI-Public: (01)10801741075961
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: UNKNOWN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2021

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
• Operator of Device: Health Professional
• Device Model Number: 918205
• Device Catalogue Number: 918205
• Device Lot Number: REEQ2740
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2021
• Initial Date Received by Manufacturer: 03/15/2021
• Supplement Date Received by Manufacturer: 09/24/2021
• Initial Report FDA Received Date: 04/07/2021
• Supplement Report FDA Received Date: 09/28/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/23/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other