MAUDE Adverse Event Report: MCKESSEN MEDICAL SURGICAL INC. MCKESSON 3CC LUER LOCK SYRINGE (STERILE); 3CC LUER LOCK SYRINGE STERILE

Model Number	MFR # 16-S3C
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/04/2017
Type of Reportable Event	Other
Event or Problem Description
When opening the single use sterile 3cc syringe, a hair was noticed inside the syringe.This clearly is an un-sterile syringe.On (b)(6) 2017 i was preparing to inject a svis patient.When i was gathering my syringes to prepare injection on patient, i unwrapped the single 3cc luer lock tip sterile syringe, and noted a hair inside the syringe.The hair is long and apparent, and clearly this syringe was not packed sterile.

• Brand Name: MCKESSON 3CC LUER LOCK SYRINGE (STERILE)
• Common Device Name: 3CC LUER LOCK SYRINGE STERILE
• Manufacturer (Section D): MCKESSEN MEDICAL SURGICAL INC. ; richmond VA 23233
• MDR Report Key: 7120590
• Report Number: MW5073970
• Device Sequence Number: 11077796
• Product Code: FMF
• UDI-Device Identifier: 20612479206988
• UDI-Public: (01)20612479206988
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/04/2017

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/02/2022
• Device Model Number: MFR # 16-S3C
• Device Catalogue Number: MFR # 16-S3C
• Device Lot Number: CKDG05-02
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1