MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. ADDEASE® BINARY CONNECTOR; ADDEASE BINARY ADMIXTURE CONNECTOR

Catalog Number N7995

Device Problem Detachment Of Device Component (1104)

Patient Problems Corneal Abrasion (1789); Eye Injury (1845); Laceration(s) (1946)

Event Type  Injury  

Manufacturer Narrative

This report has been identified as b.Braun medical inc.(b)(4).The actual device involved in the reported incident was not returned for evaluation.Without the actual sample or lot number, a thorough sample analysis or batch record review could not be performed.No specific conclusions could be drawn.Based on the reported event description, it was indicated that the nurse was shaking the bag to activate the system.Per the instructions for use (ifu) for the reported catalog number, to activate the system, the bag should be squeezed or flexed -- "squeeze or flex container and position vial below container; squeeze or flex container firmly, forcing plug from spike to vial.To transfer diluent to vial, squeeze or flex and release container repeatedly until vial is approximately half full." it is also noted in the ifu, "at time of use, check to ensure addease is firmly latched to container." no adverse quality trends of this nature were identified during the complaint review process for the reported catalog number.If additional pertinent information becomes available, a follow-up report will be filed.

Event Description

As reported by the user facility: reports the pharmacy assembled an addease connector to a bag and vial, and sent the assembly to the floor.When the nurse attempted to activate it on the floor, she was shaking the bag to make the powder a liquid.As she was shaking the bag, she either hit herself in the eye or the vial popped off the addease and hit her in the eye.Follow-up information received from the reporting facility on june 15, 2016, indicated that the nurse was sent to urgent care where she was diagnosed with a corneal abrasion.At follow-up visits, her eye continued to get worse.The nurse then went to an ophthalmologist and was diagnosed with a corneal laceration.The ophthalmologist indicated the nurse should have had surgery at the time of the incident, but too much time had now passed.The nurse was given a contact lens to apply pressure to the laceration as the two sides of the laceration started to overlap and they did not want it to scar.The contact lens worked and the eye healed nicely.

• Brand Name: ADDEASE® BINARY CONNECTOR
• Type of Device: ADDEASE BINARY ADMIXTURE CONNECTOR
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd.; allentown PA 18109
• Manufacturer Contact: robert hubert ; 901 marcon blvd.; allentown, PA 18109 ; 6102660500
• MDR Report Key: 5793669
• MDR Text Key: 49508054
• Report Number: 2523676-2016-00461
• Device Sequence Number: 1
• Product Code: LHI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090905
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 05/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Nurse
• Device Catalogue Number: N7995
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention