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

Model Number UNKNOWN PRODUCT-MED

Device Problems Break (1069); Difficult to Remove (1528)

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

Event Date 02/04/2021

Event Type  Injury  

Manufacturer Narrative

The lot number was not provided, but photos were provided for investigation.The reported issue and photos were sent to the supplier for investigation.Reviewed of the photos provided revealed the size of the tube appear to be 10fr.Without the actual lot number, the device history record could not be verified.However, the supplier checked the device history record for the year 2020 and learned no process issues were recorded, including inspection for incoming goods, processing and finished goods.Supplier did testing with some 10fr tubes from retained samples of lot 210302.Testing revealed the breaking forces were all within relevant requirements.This issue is believed to be an isolated incident.We are not able to conduct further investigation regarding this complaint.With the information provided, photos, and testing of retained samples, we are unable to confirm the root cause for the reported failure.We have informed the production line about this complaint and will monitoring trends for this defect.No additional action will be taken at this time.

Event Description

Customer reported there was resistance during removal of hemovac drain and it broke off leaving a piece inside of the patient¿s lumbar area.Surgical procedure required to remove the broken piece and it was retrieved without further incident.Patient doing fine.The product number provided is (44-2592 or 44-2593) for reservoir kit with pvc round drain 400 ml jackson-pratt wound drainage.The numbers provided are not product numbers.

• Brand Name: UNKNOWN PRODUCT-MED
• Type of Device: APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED
• Manufacturer (Section D): SGP01 SINGAPORE; 10 kallang avenue , #10-10/18; singapore 33951 0; SN 339510
• Manufacturer (Section G): SGP01 SINGAPORE; 10 kallang avenue , #10-10/18; singapore 33951 0; SN 339510
• Manufacturer Contact: patricia tucker ; 3651 birchwood drive; waukegan, IL 60085
• MDR Report Key: 11750006
• MDR Text Key: 248164606
• Report Number: 1423537-2021-00630
• Device Sequence Number: 1
• Product Code: GCY
• UDI-Device Identifier: 10192253016444
• UDI-Public: 10192253016444
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN PRODUCT-MED
• Device Catalogue Number: UNKNOWN PRODUCT-MED
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/01/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention