MAUDE Adverse Event Report: SYRINGE 10ML LL EUROGRAPHICS; PISTON SYRINGE

Model Number 300912

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/06/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported two syringe 10ml ll eurographics were damaged had leakage issues.The following information was provided by the initial reporter, translated from (b)(6): "on the 10ml syringe, we had a large crack on two syringes this week.This caused leakage.".

Manufacturer Narrative

H.6.Investigation: two photos, an opened blisterpak from batch #1082907, and a loose 10ml syringe (p/n 300912) were received.The sample was visually evaluated.The syringe was observed to have a large crack outside of the print area extending from the 1ml grad line down to the 9ml grad line.The damage observed was non-conforming per product specification.Potential root cause for the cracked barrel defect is associated with the assembly process.These conditions are occurring at/below their expected frequency.Therefore, no corrective action is required at this time.Batch #1082907 is considered in compliance with our product specification requirements.A device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.H3 other text : see h.10.

Event Description

It was reported two syringe 10ml ll eurographics were damaged had leakage issues.The following information was provided by the initial reporter, translated from dutch: "on the 10ml syringe, we had a large crack on two syringes this week.This caused leakage.".

• Brand Name: SYRINGE 10ML LL EUROGRAPHICS
• Type of Device: PISTON SYRINGE
• MDR Report Key: 12573185
• MDR Text Key: 274743052
• Report Number: 1213809-2021-00688
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903009122
• UDI-Public: 30382903009122
• Combination Product (y/n): N
• PMA/PMN Number: K110771
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 10/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 300912
• Device Catalogue Number: 300912
• Device Lot Number: 1082907
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2021
• Date Manufacturer Received: 10/12/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/23/2021
• 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