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

Catalog Number 405199

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/05/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).

Event Description

It was reported that syringe epilor plastic lor 7 ml ls bns stopper separated from the plunger on 3 occasions during use.The following information was provided by the initial reporter: material no: 405199, batch no: 9234788.It was reported that the rubber stopper separates from the plunger when drawing up sodium chloride.

Manufacturer Narrative

The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 8/18/2020.H.6.Investigation: a device history record review was performed for provided lot number 9234788 and the review did not reveal any detected quality issues during the production process that could have contributed to this reported incident.To aid in the investigation of this issue, both picture and physical samples were returned for evaluation by our quality engineer team.Through examination of the picture samples, the stopper was observed separated from the plunger component.The returned defective physical sample was examined and no signs of deformation that could have resulted in the separation were observed.The components were reassembled and the syringe was tested several times to verify that the components did not re-separate during use.Three additional physical samples were returned; however, the samples did not show any signs of defect.Based on the investigation results an exact cause for this incident could not be determined.H3 other text : see h.10.

Event Description

It was reported that syringe epilor plastic lor 7ml ls bns stopper separated from the plunger on 3 occasions during use.The following information was provided by the initial reporter: material no: 405199, batch no: 9234788.It was reported that the rubber stopper separates from the plunger when drawing up sodium chloride.

• Brand Name: SYRINGE EPILOR PLASTIC LOR 7ML LS BNS
• Type of Device: ANESTHESIA CONDUCTION KIT
• MDR Report Key: 10452129
• MDR Text Key: 205301826
• Report Number: 9610847-2020-00260
• 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: other,user facility
• Type of Report: Initial,Followup
• Report Date: 09/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 405199
• Device Lot Number: 9234788
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2020
• Date Manufacturer Received: 08/05/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/22/2019
• 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