MAUDE Adverse Event Report: SYNAPTIVE MEDICAL INC. SYNAPTIVE TRACKABLE SUCTION; VACUUM-POWERED BODY FLUID SUCTION APPARATUS

Model Number N/A

Device Problem Material Fragmentation (1261)

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

Event Date 04/13/2021

Event Type  malfunction  

Manufacturer Narrative

During an in-house inspection on (b)(6) 2021 multiple samples were identified with visible burrs/metal filings affixed within the suction tube interior.To date, there have been no complaints and no known patient injuries related to this defect.This recall affects all versions and models of synaptive¿ trackable suction.Note: all affected serial numbers and udis have not been included in this report due to space constraints.

Event Description

On (b)(6) 2021, during an in-house inspection, affixed burrs/metal filings were observed on the suction tube inner perimeter.Further investigation revealed a production issue, which has resulted in the decision to recall the affected product.

• Brand Name: SYNAPTIVE TRACKABLE SUCTION
• Type of Device: VACUUM-POWERED BODY FLUID SUCTION APPARATUS
• Manufacturer (Section D): SYNAPTIVE MEDICAL INC.; 555 richmond street w.; suite 800; toronto, ontario M5V 3 B1; CA M5V 3B1
• Manufacturer (Section G): SYNAPTIVE MEDICAL INC.; 555 richmond street w.; suite 800; toronto, ontario M5V 3 B1; CA M5V 3B1
• Manufacturer Contact: carly desmond ; 555 richmond street w.; suite 800; toronto, ontario M5V 3-B1 ; CA M5V 3B1
• MDR Report Key: 11820012
• MDR Text Key: 253206200
• Report Number: 3012075008-2021-00001
• Device Sequence Number: 1
• Product Code: GCX
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 05/12/2021

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
• Device Operator: No Information
• Device Model Number: N/A
• Device Catalogue Number: SYN-0657, SYN-0783
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/13/2021
• Initial Date FDA Received: 05/13/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1