MAUDE Adverse Event Report: SYRINGE EPILOR PLASTIC LOR 7ML LS BNS; ANESTHESIA CONDUCTION KIT

Catalog Number 405199

Device Problems Break (1069); Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/19/2020

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.(b)(4).

Event Description

It was reported that the syringe epilor plastic lor 7ml ls bns was damaged and failed to function during use.The following information was provided by the initial reporter: defect: defective component, failure to function: defect description: faulty 7 ml ls epilor lor, detected: during use, no patient injury.

Manufacturer Narrative

H.6.Investigation: as no physical sample, picture sample, lot number, or defect details were provided for evaluation by our quality engineer team, a complete investigation could not be performed.Based on the limited investigation results, a cause for the reported incident could not be determined.As a lot number is unknown for this incident, a device history record review cannot be completed.

Event Description

It was reported that the syringe epilor plastic lor 7ml ls bns was damaged and failed to function during use.The following information was provided by the initial reporter: defect: defective component, failure to function.Defect description: faulty 7 ml ls epilor lor.Detected: during use, no patient injury.

• Brand Name: SYRINGE EPILOR PLASTIC LOR 7ML LS BNS
• Type of Device: ANESTHESIA CONDUCTION KIT
• MDR Report Key: 10933082
• MDR Text Key: 219172990
• Report Number: 2618282-2020-00101
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• PMA/PMN Number: K925902
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other
• Type of Report: Initial,Followup
• Report Date: 01/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 405199
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/04/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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