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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC. SYR103010Z

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MEDLINE INDUSTRIES INC. SYR103010Z Back to Search Results
Catalog Number SYR103010Z
Device Problem Physical Resistance/Sticking (4012)
Patient Problem No Code Available (3191)
Event Date 07/11/2019
Event Type  malfunction  
Manufacturer Narrative
It was reported that while administering intramuscular medroxyprogesterone, with the needle already puncturing patient's deltoid, the syringe's plunger was unable to be moved to push the medication. Per report, during inspection prior to use, were there no issues noted with the syringe. It was added that there was no difficulty experienced during medication aspiration from the vial. A one-inch needle (needle gauge size not reported) was used to draw up medication and another one-inch needle (needle gauge size not reported) was used to administer medication to the patient. After the syringe's plunger failed to push the medication, the injection needle was withdrawn from the patient, the needle was changed, and another injection site (about an inch below initial left deltoid injection) was cleaned/prepped. The same syringe (initially with plunger unable to push medication) could be pushed halfway and patient received only half of the intended dose (0. 5 ml). A new syringe was reportedly obtained and another 0. 5 ml of the medication was given intramuscularly into the patient's right deltoid. The patient reportedly received three injections to administer full amount of medication needed. There was no serious injury or need for follow-up related to the reported event. Due to the reported incident of syringe's plunger unable to be moved to push medication and the subsequent need for additional injections, this medwatch is being filed. A sample is not available to be returned for evaluation. A definitive root cause for the reported 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 the syringe's plunger was unable to be moved to push the medication resulting in the patient requiring additional intramuscular injections.
 
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Type of DeviceSYR103010Z
Manufacturer (Section D)
MEDLINE INDUSTRIES INC.
three lakes drive
northfield IL 60093
Manufacturer Contact
bermon punzalan
three lakes drive
northfield, IL 60093
MDR Report Key8903347
MDR Text Key161597719
Report Number1417592-2019-00122
Device Sequence Number1
Product Code FMF
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
Type of Report Initial
Report Date 08/16/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/16/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberSYR103010Z
Device Lot Number190120
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/19/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 08/16/2019 Patient Sequence Number: 1
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