MAUDE Adverse Event Report: FRESENIUS KABI VIAL ; CONTAINER I. V.

Lot Number AHD702

Device Problems Detachment Of Device Component (1104); Material Fragmentation (1261)

Patient Problem No Information (3190)

Event Date 06/21/2017

Event Type  malfunction  

Event Description

Vancomycin 1 gram via ndc 63323-284-20, lot ahd702 exp: 12/2018, mfr: fresenius kabi used with vial mate system and a normal saline 250mg bag, mfr: baxter, lot #y231373, exp: 10/2018.When vial mate system was activated, the vial was cored and grey piece of rubber was floating in the bag.Note: we are contacting the mfr of the vial mate and they will most likely want the product sent to them.

• Brand Name: VIAL
• Type of Device: CONTAINER I. V.
• Manufacturer (Section D): FRESENIUS KABI
• MDR Report Key: 6662969
• MDR Text Key: 78375345
• Report Number: MW5070583
• Device Sequence Number: 1
• Product Code: KPE
• UDI-Device Identifier: 6332328420
• UDI-Public: 63323-284-20
• 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: 06/21/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2018
• Device Lot Number: AHD702
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Weight: 108