MAUDE Adverse Event Report: AMERIAN CONTRACT SYSTEMS FHNE25AB (NEURO PACK)

Model Number	FHNE25AB (NEURO PACK)
Medical Device Problem Code	Flaked (1246)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product involved in the report was not available for evaluation.Upon completion of the investigation, a follow-up report will be filed.All information reasonably known as of 24apr2023 has been included in this medical device report.This product incident is documented in the complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21 cfr 803, in compliance with the medical device reporting requirement and should not be considered to be an admission that a product is defective or has caused serious injury.H3 other text : device not returned.
Event or Problem Description
Surgical drape material is coming off.Bits of the material have become loose on the surgical field as a result.The end user's hands and arms are in contact with the drape.The surgeon and or staff are concerned that the debris may come in contact with the surgical incision.The surgical drape 13231 is a component of the acs nuero pack.The complaint surgical drape was manufactured by o&m halyard inc.
Additional Manufacturer Narrative
The product involved in the report was not available for evaluation.Based on the investigation no root causes can be established, as a lot number, sample or photo was not provided.The incident was noticed in a cpt pack.This is an isolated event and personnel was notified about the issue to create awareness.All information reasonably known as of 15jun2023 has been included in this medical device report.This product incident is documented in the complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that a product is defective or has caused serious injury.

• Brand Name: FHNE25AB (NEURO PACK)
• Common Device Name: NEURO PACK
• Manufacturer (Section D): AMERIAN CONTRACT SYSTEMS; 2610 ne industrial drive; suite 220; kansas city MO 64120
• Manufacturer (Section G): AMERICAN CONTRACT SYSTEM; 2610 ne industrial drive; suite 220; kansas city MO 64120
• Manufacturer Contact: nichole early ; 1 edison drive; alpharetta, GA 30005 ; 8287820529
• MDR Report Key: 16812357
• Report Number: 3003419114-2023-00001
• Device Sequence Number: 17587654
• Product Code: OJG
• UDI-Device Identifier: 00191072178213
• UDI-Public: 00191072178213
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2023

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: Other
• Device Model Number: FHNE25AB (NEURO PACK)
• Device Catalogue Number: FHNE25AB (NEURO PACK)
• Device Lot Number: 983231
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2023
• Supplement Date Received by Manufacturer: 05/25/2023
• Initial Report FDA Received Date: 04/25/2023
• Supplement Report FDA Received Date: 06/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sex: Unknown