MAUDE Adverse Event Report: SOUTHMEDIC, INC. MULTI DOSE INHALER ADAPTER; VENTILATOR ADAPTER FOR USE WITH MDI

Model Number SMDIA-1000

Device Problems Material Too Rigid or Stiff (1544); Material Integrity Problem (2978)

Patient Problem Abrasion (1689)

Event Type  Injury  

Event Description

Rough edges on mdi adaptor scratched a patient's neck.A nurse also cut her finger on the same area of the product while applying the canister.Affected patient is a premature infant.Reporter indicated the rough area was where the ventilator circuit was positioned at the patient's trachea.Healthcare facility is pediatric connection, (b)(6).Event sample is not available to be returned.Initial importer of record did not report this incident to the fda.(b)(4) part number: smdia-1000; lot number: unknown.

• Brand Name: MULTI DOSE INHALER ADAPTER
• Type of Device: VENTILATOR ADAPTER FOR USE WITH MDI
• Manufacturer (Section D): SOUTHMEDIC, INC.; 50 alliance blvd.; barrie, ontario L4M 5 K3; CA L4M 5K3
• Manufacturer (Section G): SOUTHMEDIC INC.; 50 alliance blvd.; L4M 5 K3; CA L4M 5K3
• Manufacturer Contact: tish whitehead ; 50 alliance blvd.; CA L4M 5K3
• MDR Report Key: 6736001
• MDR Text Key: 80807359
• Report Number: 8022032-2017-00001
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101953
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/15/2017

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
• Device Operator: Nurse
• Device Model Number: SMDIA-1000
• Device Catalogue Number: SMDIA-1000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/12/2017
• Initial Date FDA Received: 07/24/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 14 DA
• Patient Weight: 1