MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; SYRINGE, LUER LOCK, STERILE, 3ML

Catalog Number	SYR103010
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	04/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that during a scheduled immunization of a patient (age unidentified), tdap vaccine leaked from behind and onto the plunger of the 3 ml syringe.Per report, 0.5 ml of the tdap vaccine was placed inside the syringe and leaking was noted as medical assistant was pushing the plunger to administer the vaccine into the patient.The medical assistant informed the primary care physician that patient did not receive the entire dose of the administered vaccine and patient was told of the need for an additional dose to assure immunity.Per report, the patient was rescheduled to receive the additional dose a month later and patient elected to cancel appointment.Reportedly, the appointment was now scheduled for (b)(6) 2019.Due to the reported event and need for additional vaccine, this medwatch is being filed.The sample was returned for evaluation and the complaint was confirmed.A definitive root cause for the reported issue could not be determined at this time.No additional information is available.If additional information becomes available, a supplemental medwatch will be filed.
Event or Problem Description
It was reported that tdap vaccine leaked from behind and onto the plunger of the 3 ml syringe resulting in patient not receiving the full dose of the vaccine.Patient was scheduled to receive another dose of the vaccine.

• Common Device Name: SYRINGE, LUER LOCK, STERILE, 3ML
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 8718878
• Report Number: 1417592-2019-00098
• Device Sequence Number: 14084091
• Product Code: FMF
• UDI-Device Identifier: 10080196310166
• UDI-Public: 10080196310166
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 06/20/2019

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: SYR103010
• Device Lot Number: 180620
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/22/2019
• Initial Report FDA Received Date: 06/20/2019
• 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