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

Model Number 1650050

Device Problems Break (1069); Entrapment of Device (1212); Fracture (1260); Migration (4003)

Patient Problems Foreign Body In Patient (2687); Cough (4457); Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/09/2021

Event Type  Injury  

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 Description

A facility reported that a surgeon performed a steroid injection on a patient using an oro-tracheal injector needle (1650050).When he tried to remove the needle from the cannula, he noticed the needle broke off.The needle was stuck in the patient for approximately 15 minutes before being retrieved from the patient's throat.It was reported that this was unpleasant for the patient to tolerate; however, the patient was unharmed and is currently doing well.

Event Description

N/a.

Manufacturer Narrative

The following was received via medwatch report number mw5106022 on (b)(6) 2022: during vocal cord injection, part of the microfrance and integra orotracheal needle broke off in the patient's throat.The plastic cover.There was a small piece of the plastic sheath that was still attached onto the cannula where the equipment had fractured.After a few attempts lasting approximately 15 minutes, the needle piece was retrieved.

Event Description

N/a.

Manufacturer Narrative

The following was received via medwatch mdr report # mw5106045 on (b)(6) 2022: patient was undergoing injection of dexamethasone into bilateral vocal folds in the superficial lamina propria for bilateral posterior fibro vascular lesions of vocal folds.During the procedure the needle was advanced into the left and then into the right vocal fold and 1cc was injected into the left slp and 1cc into the right slp.Following the procedure the cannula was removed and it was noticed that the needle tip with plastic was fractured.The scope was replaced and the needle identified in vallecula.They attempted laryngoscopy guided removal with forceps but were unable to remove and it migrated to hypopharynx.They attempted removal with biopsy forceps via working channel which was unsuccessful.After the patient coughed and needle was identified in oropharynx and removed with forceps.The patient was awake during the procedure.The manufacturer was notified.The provider is an experience md having perform this procedure frequently.He had never encountered breakage of a needle during the procedure in the past.

Manufacturer Narrative

Oro-tracheal injector needle (1650050) was returned for evaluation: device history record (dhr): the dhr was reviewed and no abnormalities related to the reported issue were observed.Failure analysis: the returned 1650050 needles are in unused condition, and still in their original packaging.The damaged needle was not received.The returned needles met specification and had no visible defect.However, the customer provided an image of the needle; the broken needle had its end broken off, potentially due to rough handling, or a dulled tip due to being used in multiple injections as a single use needle.Conclusion: the reported complaint is confirmed.Per the photo provided of the damaged needle, the 1650050 needle had its tip broken off due to rough handling or a dulled tip.No manufacturing, workmanship, or material deficiency has been identified.No further investigation required based on the acceptability of risk and no adverse trends identified.This will be monitored and trended going forward.

Event Description

N/a.

• Brand Name: NEEDLE 1650050 5PK ORO-TRACHEAL INJECTOR
• Type of Device: PFM11
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 13110239
• MDR Text Key: 282954188
• Report Number: 3014334038-2021-00266
• Device Sequence Number: 1
• Product Code: GAA
• UDI-Device Identifier: 10381780075097
• UDI-Public: 10381780075097
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1650050
• Device Catalogue Number: 1650050
• Device Lot Number: W2105118
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/09/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1