MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; SYR103010Z

Catalog Number	SYR103010Z
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	07/11/2019
Type of Reportable Event	Malfunction
Additional 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medication to the patient.After the syringe's plunger failed to push the medication, the injection needle was withdrawn from the patient, the needle was changed, and another injection site (about an inch below initial left deltoid injection) was cleaned/prepped.The same syringe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 or Problem 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.

• Common Device Name: SYR103010Z
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 8903347
• Report Number: 1417592-2019-00122
• Device Sequence Number: 18961260
• Product Code: FMF
• UDI-Device Identifier: 10080196310166
• UDI-Public: 10080196310166
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/16/2019

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: SYR103010Z
• Device Lot Number: 190120
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/19/2019
• Initial Report FDA Received Date: 08/16/2019
• 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
• Patient Age: 15 YR
• Patient Weight: 55