MAUDE Adverse Event Report: GLOBAL MEDICAL INSULIN SYRINGE 0.5ML 31G 5/16"

Device Problems Break (1069); Difficult to Remove (1528); Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 04/01/2014

Event Type  No Answer Provided  

Event Description

Customer pr notified our call center rep that two syringe needles broke off in to his stomach.He told us he was able to remove one needle from his stomach but he believed that one needle still remained in his stomach.We advised him to immediately seek medical treatment.Customer pr told the rep that he believed the needles were defective and that is why they broke in his stomach.The needle brand was global syringe needles 0.5ml 31g 5/16".We contacted global to notify them of the event and the rep from global said this was the first reported incident of an event of this nature.Dates of use: (b)(6) 2013 - (b)(6) 2014.

• Brand Name: INSULIN SYRINGE 0.5ML 31G 5/16"
• Type of Device: INSULIN SYRINGE
• Manufacturer (Section D): GLOBAL MEDICAL; jupiter FL 33468
• MDR Report Key: 3750119
• MDR Text Key: 18797422
• Report Number: MW5035608
• Device Sequence Number: 1
• Product Code: FMF
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 04/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Other Device ID Number: 90166015655
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Patient Sequence Number: 1
• Patient Age: 76 YR