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

Model Number	003984-901
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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.
Additional 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)
• Common Device Name: 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
• Report Number: 3003790304-2023-00102
• Device Sequence Number: 15048436
• Product Code: HHI
• UDI-Device Identifier: 00821925037885
• UDI-Public: 00821925037885
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K030935
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2023

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: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2023
• Supplement Date Received by Manufacturer: 11/08/2023
• Initial Report FDA Received Date: 03/07/2023
• Supplement Report FDA Received Date: 11/08/2023
• 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