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

Catalog Number SYR101272

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/07/2023

Event Type  Injury  

Manufacturer Narrative

According to the customer, an rn inserted the needle into the patient's subcutaneous tissue and when the plunger of the syringe was pushed, "the needle disconnected from the syringe and remained in the patient's subcutaneous tissue".The customer reported the medication being administered was "heparin" and it sprayed onto the patient's skin.The customer reported the needle was removed from the patient, and no additional medication was ordered by the physician because, "it was unclear how much, if any medication was actually delivered".The customer reported the patient is "doing fine", and there was no serious injury or additional medical intervention required related to the reported incident.Sample was requested for return evaluation.No additional information is available at this time.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.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 customer, an rn inserted the needle into the patient's subcutaneous tissue and when the plunger of the syringe was pushed, "the needle disconnected from the syringe and remained in the patient's subcutaneous tissue".

• 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: danielle tognocchi ; three lakes drive; northfield, IL 60093
• MDR Report Key: 16674290
• MDR Text Key: 312619117
• Report Number: 1417592-2023-00150
• 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: Other
• Type of Report: Initial
• Report Date: 04/04/2023

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: SYR101272
• Device Lot Number: 220520
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/07/2023
• Initial Date FDA Received: 04/04/2023
• 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): Other