MAUDE Adverse Event Report: GYRUS ACMI, INC. SAFETOUCH COLLECTION SYSTEM (10/PK); ABORTION SUCTION SYSTEM COLLECTION BOTTLE

Model Number 003984-901

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

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

Event Type  malfunction  

Event Description

Customer service representative reported a potential out of box failure; device was reported to fail upon installation.According to the report, the device 003984-901 berkeley safetouch collection system with tissue traps case was shipped in december, and the expiration date is november, making the collection system unusable.There is no patient involvement on this reported event.No harm was reported as a result of the event.

Manufacturer Narrative

Technical assistance center (tac) communication with the customer representative reported that the issue was noticed weeks ago and the subject device was removed from inventory.A return authorization material (rma) was issued to the customer for the return of the device.In a follow up communication, customer stated that the box only has one date stating, "i think it was mistaken as an expiration instead of a date of manufacture." to date, the device has not yet been received for evaluation.Supplemental report(s) will be submitted should any relevant new information is available and or received.Investigation is ongoing.This report will be supplemented accordingly following investigation.

Manufacturer Narrative

This supplemental report is to inform that upon further review, this is not a reportable malfunction.The initial medwatch reported the customer received the subject device past the expiration date; however; the subject device does not have an expiration date.It was communicated to the customer that this date was the date the subject device was manufactured and the device is safe to use.There is no reportable event or malfunction of the device.

• Brand Name: SAFETOUCH COLLECTION SYSTEM (10/PK)
• Type of Device: ABORTION SUCTION SYSTEM COLLECTION BOTTLE
• Manufacturer (Section D): GYRUS ACMI, INC.; 800 west park drive; westborough MA 01581
• Manufacturer (Section G): GYRUS ACMI, INC.; 800 west park drive; westborough MA 01581
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16493517
• MDR Text Key: 310870561
• Report Number: 3003790304-2023-00102
• Device Sequence Number: 1
• Product Code: HHI
• UDI-Device Identifier: 00821925037885
• UDI-Public: 00821925037885
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K030935
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 003984-901
• Device Lot Number: 2070101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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