MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS RAPIDLYTE 3ML SYRINGE

Catalog Number 10320248

Device Problem Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/09/2020

Event Type  malfunction  

Manufacturer Narrative

The issue was resolved by cleaning the affected areas.Tests were run on those exposed and no medical treatment or intervention was required.No leakage, cracks, or damage was observed on any other syringes of the same batch.Siemens has requested that the remaining unused syringes be returned to the manufacturer.The cause of this event is unknown.

Event Description

The customer reported an incident where a syringe chamber was cracked and blood spurted onto the patient and operator.There was no reported injury due to this event.

Manufacturer Narrative

Siemens has requested the remaining syringes to be returned to the manufacturer for investigation, multiple times.There has been no communication from the customer.An investigation will not be possible.The cause of this event is unknown.

• Brand Name: RAPIDLYTE 3ML SYRINGE
• Type of Device: RAPIDLYTE 3ML SYRINGE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS; 511 benedict avenue; tarrytown, ny
• MDR Report Key: 9922418
• MDR Text Key: 187450387
• Report Number: 3002637618-2020-00014
• Device Sequence Number: 1
• Product Code: IQG
• 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
• Report Date: 05/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/12/2021
• Device Catalogue Number: 10320248
• Device Lot Number: 3691444
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1