MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS RAPIDLYTE 3 ML L/S SYRINGE FILTER CAP

Catalog Number 10707031

Device Problems Material Puncture/Hole (1504); Use of Device Problem (1670)

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

Event Date 06/11/2019

Event Type  malfunction  

Manufacturer Narrative

Siemens has requested the syringes be provided for investigation.The customer stated that the operator washed their eyes with eye wash solution and did not seek medical intervention.

Event Description

The customer reported that a rapidlyte 3 ml l/s syringe sprayed blood while aspirating a sample.The blood sprayed in the operator's eye.The operator was not wearing safety glasses.

Manufacturer Narrative

(b)(6) 2019: update: the supplier has indicated there was a clearance delay that delayed the investigation.The shipment has now been released and is on its way to the investigation site.

Manufacturer Narrative

(b)(6) 2019: update: biohazard packaging is required for the syringes to be sent to the supplier for investigation.The containers that were shipped were too small for the used syringes.Siemens is waiting for the larger containers to be sent.

Manufacturer Narrative

Investigation completed: review of manufacturing records for lot # 3673346 revealed no discrepancies or anomalies.A total of three used syringes were received for analysis.No original packaging was returned.Visual examination of the syringes revealed holes in the molding gates of two syringe barrels.A similar hole was found in the shoulder of the third syringe's barrel.In response to these observations, notifications were provided to the supplier for the syringe barrel component as well as the manufacturer's personnel.Complaint data will continue to be monitored for new information, with further actions taken accordingly.

• Brand Name: RAPIDLYTE 3 ML L/S SYRINGE FILTER CAP
• Type of Device: RAPIDLYTE 3 ML L/S SYRINGE FILTER CAP
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS; 511 benedict avenue; tarrytown NY 10591
• MDR Report Key: 8764885
• MDR Text Key: 164913912
• Report Number: 3002637618-2019-00077
• Device Sequence Number: 1
• Product Code: GIO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 10707031
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1