MAUDE Adverse Event Report: SYRINGE 60ML E/T; PISTON SYRINGE

Model Number	300866
Medical Device Problem Codes	Break (1069); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 2007082, medical device expiration date: 2025-06-30, device manufacture date: 2020-07-27.Medical device lot #: 2101084, medical device expiration date: 2025-12-31, device manufacture date: 2021-01-22.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that the syringe 60ml e/t plunger rod broke after drawing up medication.Additionally, another syringe leaked past the stopper when drawing up medicine.The following information was provided by the initial reporter: "needle wall breaks after drug withdrawal.Leakage from the syringe after the medicine is drawn".
Event or Problem Description
It was reported that the syringe 60ml e/t plunger rod broke after drawing up medication.Additionally, another syringe leaked past the stopper when drawing up medicine.The following information was provided by the initial reporter: "needle wall breaks after drug withdrawal.Leakage from the syringe after the medicine is drawn.".
Additional Manufacturer Narrative
H6: investigation summary: photos received for investigation, upon visual inspection of the pictures, it can be observed the plunger is broken from lot 2007082.Upon visual inspection of the picture of the syringe from lot 2101084 no leakage past the stopper can be seen and no molding defect or hit is detected that can lead to the defect noticed by customer.A device history review was performed for the reported lot 2007082, 2101084 no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Possible root cause for damaged plunger can be a result of a hit during manufacturing process.Areas where pieces are transported in manufacturing area are protected to avoid damage on the product.Based on the available information we are not able to identify a root cause for leakage related to the manufacturing process at this time.Product undergoes inspections throughout the manufacturing process to ensure the quality and functionality of the device, including verification all critical dimensions are within specification and there is no damage on the product.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text : see h10.

• Brand Name: SYRINGE 60ML E/T
• Common Device Name: PISTON SYRINGE
• MDR Report Key: 12363453
• Report Number: 3003152976-2021-00501
• Device Sequence Number: 3822152
• Product Code: FMF
• UDI-Device Identifier: 30382903008668
• UDI-Public: 30382903008668
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K980987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: 300866
• Device Catalogue Number: 300866
• Device Lot Number: SEE SECTION H.10.
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/27/2021
• Supplement Date Received by Manufacturer: 10/12/2021
• Initial Report FDA Received Date: 08/24/2021
• Supplement Report FDA Received Date: 11/02/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1