MAUDE Adverse Event Report: SGP01 SINGAPORE UNKNOWN PRODUCT-MED; APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED

Model Number	UNKNOWN PRODUCT-MED
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is ongoing.A follow up report will be filed.
Event or Problem Description
Customer reported using a hemovac suction drain reservoir during left knee procedure.Reportedly, the drain was being removed per usual routine postoperative order 22 hours later when end of drain broke off in patient.Broken piece surgically removed and patient routinely discharged the next day.They were able to wrap up the drain in a biohazard bag to return for investigation.
Additional Manufacturer Narrative
One piece of the complaint sample was returned for investigation and forwarded to our supplier.The lot number was not provided.The supplier was not able to identify the returned piece of the complaint sample.Investigation revealed the hole in the barium tube of the returned sample is marked with three rectangular black bars.The products provided by the supplier does not include rectangular black bars; therefore, the returned sample is from a different manufacturer.The customer was notified about this discovery and instructed to contact the correct manufacturer of the product to report the complaint.

• Brand Name: UNKNOWN PRODUCT-MED
• Common Device Name: APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED
• Manufacturer (Section D): SGP01 SINGAPORE; 10 kallang avenue , #10-10/18; singapore 33951 0; SN 339510
• MDR Report Key: 11979986
• Report Number: 1423537-2021-00642
• Device Sequence Number: 11898348
• Product Code: GCY
• UDI-Device Identifier: 10192253016444
• UDI-Public: 10192253016444
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: UNKNOWN PRODUCT-MED
• Device Catalogue Number: UNKNOWN PRODUCT-MED
• Device Lot Number: 44-2592
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/18/2021
• Supplement Date Received by Manufacturer: 05/18/2021
• Initial Report FDA Received Date: 06/10/2021
• Supplement Report FDA Received Date: 08/16/2021
• Patient Sequence Number: 1
• Patient Weight: 78