MAUDE Adverse Event Report: BD BD INSULIN SYRINGE; SYRINGE, PISTON

Device Problem Entrapment of Device (1212)

Patient Problems Unspecified Infection (1930); Inflammation (1932); Device Embedded In Tissue or Plaque (3165)

Event Date 09/09/2019

Event Type  Injury  

Event Description

Caller reported syringe needle broke and was entrapped in her stomach.She went to the er and had an x-ray, however the needle could not be visualized.The surgeon informed her to return if there are signs of infection.On (b)(6) 2019, caller noticed an infection and inflammation in her abdomen.She returned to the surgeon and had the needle removed on (b)(6) 2019.

• Brand Name: BD INSULIN SYRINGE
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): BD
• MDR Report Key: 9315967
• MDR Text Key: 166353361
• Report Number: MW5091013
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 85 YR