MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; SYR W/NDLE,HYPODERM,TB,27GX 1/2", 1ML

Catalog Number SYR101272

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 06/30/2022

Event Type  Injury  

Manufacturer Narrative

According to the facility on (b)(6) 2022 during a medication injection the needle became detached from the syringe while in the patient and the patient did not receive the full dose of medication.Per the facility the injection was inserted in the patients right lower quadrant of the abdomen in the patient's 'pinched adipose tissue'.Per the facility during the injection when the plunger was depressed, the syringe came apart from the needle and the medication 'exploded out of the syringe'.Per the facility the staff member administering the injection performed the administration as 'they've always done for the past 10 years'.According to the facility the patient did not receive their full dose of medication as it was unclear how much medication was administered prior to the syringe detaching.Per the facility the patient is reporting to be doing 'fine'.The device that was used is not available to be returned for evaluation.No additional information is available.Due to the reported incident and in an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

Event Description

According to the facility on (b)(6) 2022 during a medication injection the needle became detached from the syringe while in the patient and the patient did not receive the full dose of medication.

• Type of Device: SYR W/NDLE,HYPODERM,TB,27GX 1/2", 1ML
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: justin herrmann ; three lakes drive; northfield, IL 60093
• MDR Report Key: 15071107
• MDR Text Key: 296288123
• Report Number: 1417592-2022-00113
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 10080196448814
• UDI-Public: 10080196448814
• 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
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: SYR101272
• Device Lot Number: 89722030001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention