MAUDE Adverse Event Report: MEDLINE INDUSTRIES MEDLINE SALINE SYRINGE 10ML

Catalog Number	DYNDA1123C
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/19/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Patient having labs drawn via pac.Faulty syringe with crack which caused blood to spill all over patient's clothing.

• Brand Name: MEDLINE SALINE SYRINGE 10ML
• Common Device Name: MEDLINE SALINE SYRINGE 10ML
• Manufacturer (Section D): MEDLINE INDUSTRIES; northfield IL
• MDR Report Key: 7478911
• Report Number: MW5076956
• Device Sequence Number: 16508089
• Product Code: DXT
• UDI-Device Identifier: 10889942559725
• UDI-Public: 10889942559725
• Combination Product (Y/N): N
• Initial Reporter State: VT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/30/2018

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: Health Professional
• Device Expiration Date: 09/30/2020
• Device Catalogue Number: DYNDA1123C
• Device Lot Number: 18CB9311
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 68 YR