MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD NEEDLE 1650050 5PK ORO-TRACHEAL INJECTOR; PFM11

Catalog Number	1650050
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
Event or Problem Description
The following was reported via medwatch/mdr report# mw5172110: a facility reported that during an "oro-tracheal" procedure, the needle 1650050 5pk oro-tracheal injector (1650050) broke while being used to inject kenalog to the patient's subglottic area.The surgery was paused, and the needle was retrieved from the subglottic tissue in its entirety.A new oro-trachea needle was opened to compare sizes and to ensure that the entire broken needle was retrieved from the patient.Pictures were taken as proof of retrieval and as a comparison to the whole, unbroken needle.There was no injury, death, or surgical delay reported.
Additional Manufacturer Narrative
Updated fields: d9, e4, g3, g6, h2, h3, h6, h11.The needle 1650050 5pk oro-tracheal injector (1650050) was not returned for evaluation: the device history record (dhr) was reviewed, and no abnormalities related to the reported issue were observed.Failure analysis: there has been no return of product for evaluation.The customer stated the product was disposed of.The provided images do not show the complaint device; instead, they show a different item for comparison.No conclusion can be drawn from the images.Root cause analysis: there has been no return of product for evaluation.The definitive root cause cannot be determined.The issue of breaking may be the result of rough handling or bending of the needle.
Event or Problem Description
N/a.

• Brand Name: NEEDLE 1650050 5PK ORO-TRACHEAL INJECTOR
• Common Device Name: PFM11
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA 02048
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA 02048
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 22642300
• Report Number: 3014334038-2025-00107
• Device Sequence Number: 21032299
• Product Code: GAA
• UDI-Device Identifier: 10381780075097
• UDI-Public: 10381780075097
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2025

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 Catalogue Number: 1650050
• Device Lot Number: 7472999
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2025
• Supplement Date Received by Manufacturer: 07/29/2025
• Initial Report FDA Received Date: 07/29/2025
• Supplement Report FDA Received Date: 07/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/30/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 51 YR
• Patient Sex: Female
• Patient Weight: 93 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White