MAUDE Adverse Event Report: GBUK GROUP LIMITED ISOSAF ENFIT ORAL LIQUID SYRINGE; ENTERAL SYRINGES WITH ENTERAL SPECIFIC CONNECTORS

Catalog Number EISO-PFC-12

Patient Problem Insufficient Information (4580)

Event Type  Other  

Event Description

Received an enfit oral liquid syringes that are not marked appropriately.The syringes are made by isosaf.Lot number is c03200001.Ismp, 5200 butler pike, plymouth meeting, pa 19462.Phone: 215-947-7797.Email: merp@ismp.Org.Submission id 87957.

• Brand Name: ISOSAF ENFIT ORAL LIQUID SYRINGE
• Type of Device: ENTERAL SYRINGES WITH ENTERAL SPECIFIC CONNECTORS
• Manufacturer (Section D): GBUK GROUP LIMITED
• MDR Report Key: 18383702
• MDR Text Key: 331359418
• Report Number: MW5149464
• 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
• Report Date: 10/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Catalogue Number: EISO-PFC-12
• Device Lot Number: C03200001
• Patient Sequence Number: 1