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

Catalog Number	SYR103010Z
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that an unknown number of incidents occurred wherein the syringes' plungers came off while administering medications (testosterone cypionate), resulting in medications leaking out from inside of syringes.The patients were reportedly administered with an unknown amount of the drug and patients did not receive therapeutic dosage.It was added that the patients had to return at a later date for additional medication administration.Due to the reported event and need for additional medication administration, this medwatch is being filed.Samples are not available for evaluation.A 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 the syringes' plungers come off when administering medications.The patients had to return at a later date for additional medication administration.

• Common Device Name: SYRINGE, LUER LOCK, STERILE, 3ML
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 8898742
• Report Number: 1417592-2019-00129
• Device Sequence Number: 526230
• Product Code: FMF
• UDI-Device Identifier: 10080196310166
• UDI-Public: 10080196310166
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/15/2019

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/30/2019
• Initial Report FDA Received Date: 08/15/2019
• 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; Required Intervention