MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION VIAL MATE ADAPTERS ; SET, I.V, FLUID TRANSFER

Device Problems Material Fragmentation (1261); Contamination /Decontamination Problem (2895)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  No Answer Provided  

Event Description

We use the baxter vial mate adapters with baxter 250 ml d5w bags for our 1g vancomycin dosing.I had 2 different bags brought to me 1 week apart with significant coring of the rubber vial stopper from the vancomycin 1g vials.We are currently using the mylan 1g vancomycin vials.One of the rubber shards remained in the vial and in the other product, the shard had traveled into the bag and settled into the port where the iv tubing would have been inserted so if not noticed, would have entered into the iv tubing flowing to the patient.I can not say for sure if the problem is with the adapter or with the mylan vancomycin product.I have contacted baxter with this information as well.We immediately removed all baxter vialmate adapters from use until further information was given by the drug companies.(b)(6), access number: (b)(4).

• Brand Name: VIAL MATE ADAPTERS
• Type of Device: SET, I.V, FLUID TRANSFER
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION
• MDR Report Key: 9627294
• MDR Text Key: 177147283
• Report Number: MW5092480
• Device Sequence Number: 1
• Product Code: LHI
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 01/23/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Patient Sequence Number: 1