MAUDE Adverse Event Report: UNKNOWN ENFIT SYRINGE TAMPER EVIDENT CAP; ENTERAL SYRINGES WITH ENTERAL SPECIFIC CONNECTORS

Device Problem Product Quality Problem (1506)

Patient Problem Insufficient Information (4580)

Event Type  Other  

Event Description

The oral enfit syringe tamper evident caps can leak controlled substances if not locked in place prior to transfer.(b)(6).Submission id: (b)(4).

• Brand Name: ENFIT SYRINGE TAMPER EVIDENT CAP
• Type of Device: ENTERAL SYRINGES WITH ENTERAL SPECIFIC CONNECTORS
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 16994822
• MDR Text Key: 315968970
• Report Number: MW5117804
• Device Sequence Number: 1
• Product Code: PNR
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1