MAUDE Adverse Event Report: SYNERGY HEALTH NORTH AMERICA STERILIZATION WRAPPER

Model Number 4360

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/18/2015

Event Type  malfunction  

Manufacturer Narrative

Multiple attempts were made in order to collect additional information, such as sterilization wrapper lot number, patient information (medical history, age, weight, etc.).The actual wrapper that was involved in this event has not been returned for additional investigation.Randomly pulled samples from the final production lots have been inspected and no issues identified.The original reporter confirmed on (b)(6) 2015 that the patient outcome was good.However, based on the originally reported information stating that the procedure was significantly delayed, where no further details have been provided, the emdr was filed on (b)(6) 2015.The unsuccessful report transmission resulted in contacting the esg help desk on (b)(6) 2015 when the ticket number (b)(4) was generated.In addition to this (b)(4) was contacted on 09/18/2015 at 8:36am.Ms.(b)(6), consumer safety officer, advised to submit the mdr paper copy while the egs investigation is pending.

Event Description

Basin set-up pack had a pin hole in a wrapper that due to the location of the hole was not identified until the case was completely set up and patient was under the anesthesia.Due to the hole in a basin set-up pack wrap, the entire set-up needed to be broken down and the new basin set-up pack was opened.This caused one hour procedural delay.Patient outcome was good.

• Brand Name: STERILIZATION WRAPPER
• Manufacturer (Section D): SYNERGY HEALTH NORTH AMERICA; 6675 business pky.,suite a; elkridge MD 21075
• Manufacturer Contact: 6675 business pky.,suite a; elkridge, MD 21075 ; 4103795252
• MDR Report Key: 5094840
• MDR Text Key: 26494572
• Report Number: 0001123757-2015-00001
• Device Sequence Number: 1
• Product Code: FRG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K002968
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Report Date: 09/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 4360
• Device Catalogue Number: 4360
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/18/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention