MAUDE Adverse Event Report: PR006 PUERTO RICO-ANASCO KIT DRAIN 100CC W/7MM PERF; APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED

Model Number	SU130-1360
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported that the spine surgeon tried to place a jp drain and when he grabbed the end to pull it through the incision, the plastic literally crumbled.Piece was retrieved with no adverse effect to the patient.
Additional Manufacturer Narrative
The complaint indicates that the lot number is unknown, although the customer has two lot numbers 1200283 and 1200569 on the shelf.Therefore, the device history record was reviewed for the two lot numbers.These lot numbers showed the product was inspected and released in compliance with all requirements.The sample was not returned for investigation; therefore, an evaluation of the complaint device for deficiency of construction could not be performed and the root cause remains unknown.Although no sample was received, instructions for use evaluation was performed to confirm that the required steps to avoid breakage of the drain are available.

• Brand Name: KIT DRAIN 100CC W/7MM PERF
• Common Device Name: APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED
• Manufacturer (Section D): PR006 PUERTO RICO-ANASCO; state rd. 402 , north km 0.9; anasco PR 00610
• Manufacturer (Section G): PR006 PUERTO RICO-ANASCO; state rd. 402 , north km 0.9; anasco PR 00610
• Manufacturer Contact: patricia tucker ; 3651 birchwood drive; waukegan, IL 60085 ; 8478874151
• MDR Report Key: 16942850
• Report Number: 1423537-2023-00937
• Device Sequence Number: 7013115
• Product Code: GCY
• UDI-Device Identifier: 10192253022537
• UDI-Public: 10192253022537
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/16/2023

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: SU130-1360
• Device Catalogue Number: SU130-1360
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2023
• Initial Report FDA Received Date: 05/16/2023
• 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 Age: 83 YR
• Patient Sex: Female
• Patient Weight: 64 KG