MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP Medline; TRAY,IRRIGATION,PISTON SYRINGE,60ML,STRL

Model Number	DYND20302
Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Code	Unspecified Kidney or Urinary Problem (4503)
Date of Event	04/18/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the customer contact, the syringe "does not perform as needed".The customer reported, on 4/18 the provider stated the syringe "does not have enough strength/suction" which "did not allow for the clots to be evacuated on the floor".The customer reports, due to this, a return to the or was required for hematoma clot evacuation.A sample was requested to be returned for evaluation.It has been determined that the reported event caused or contributed to serious injury, therefore, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
Syringe did not provide enough suction.

• Brand Name: Medline
• Common Device Name: TRAY,IRRIGATION,PISTON SYRINGE,60ML,STRL
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: kelly zampella ; three lakes drive; northfield, IL 60093
• MDR Report Key: 17011153
• Report Number: 1417592-2023-00237
• Device Sequence Number: 7493229
• Product Code: KYZ
• UDI-Device Identifier: 10080196031801
• UDI-Public: 10080196031801
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: DYND20302
• Device Catalogue Number: DYND20302
• Device Lot Number: 0332209A116
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2023
• Initial Report FDA Received Date: 05/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown