MAUDE Adverse Event Report: B. BRAUN MELSUNGEN AG 250ML 167ML/HR; ELASTOMERIC INFUSION DEVICE

Model Number A1670-250

Device Problems Crack (1135); Leak/Splash (1354); Material Deformation (2976)

Patient Problem No Information (3190)

Event Date 02/27/2014

Event Type  malfunction  

Event Description

Pharmacy technician was filling accurx elastomeric device (167ml/hr 250ml) for a home infusion patient.Fill volume was 250ml.On 3 of 14 units plastic "wings" cracked, product leaked, bottom of device became deformed and top by fill port had small crack.Lot 2e0916701.Manufactured 05/2012.Expires 04/2017.Reason for use: used to compound antibiotic infusion for home infusion patie.

• Brand Name: 250ML 167ML/HR
• Type of Device: ELASTOMERIC INFUSION DEVICE
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; melsungen DE 34212
• MDR Report Key: 3667636
• MDR Text Key: 4346506
• Report Number: MW5034828
• Device Sequence Number: 1
• Product Code: MEB
• 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: 02/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2017
• Device Model Number: A1670-250
• Device Lot Number: 2E09R16701
• Other Device ID Number: A1670-250
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/04/2014
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other