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

Catalog Number SYR103010

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Code Available (3191)

Event Date 04/04/2019

Event Type  malfunction  

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 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.

• Type of Device: SYRINGE, LUER LOCK, STERILE, 3ML
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• Manufacturer Contact: bermon punzalan ; three lakes drive; northfield, IL 60093
• MDR Report Key: 8718878
• MDR Text Key: 150277572
• Report Number: 1417592-2019-00098
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 10080196310166
• UDI-Public: 10080196310166
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/22/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other