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U.S. Department of Health and Human Services

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

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MEDLINE INDUSTRIES INC. SYRINGE, LUER LOCK, STERILE, 3ML Back to Search Results
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.
 
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Type of DeviceSYRINGE, 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 Key8718878
MDR Text Key150277572
Report Number1417592-2019-00098
Device Sequence Number1
Product Code FMF
UDI-Device Identifier10080196310166
UDI-Public10080196310166
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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 Received06/20/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberSYR103010
Device Lot Number180620
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/14/2019
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/22/2019
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 Treatment Data
Date Received: 06/20/2019 Patient Sequence Number: 1
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