MAUDE Adverse Event Report: BBRAUN ONGUARD

Model Number ONGUARD

Device Problems Chemical Spillage (2894); Sediment, Precipitate Or Deposit In Device Or Device Ingredient (3021)

Patient Problem No Information (3190)

Event Date 03/05/2015

Event Type  malfunction  

Event Description

Pt to receive treanda and a cstd was used.Had issues with particulates and leakage of cstd (cstd use was the on-guard system).Dates of use: (b)(6) 2015.Diagnosis or reason for use: for treatment of follicular lymphoma.

• Brand Name: ONGUARD
• Type of Device: ONGUARD
• Manufacturer (Section D): BBRAUN; bethlehem PA 18018 352
• MDR Report Key: 4627515
• MDR Text Key: 5760578
• Report Number: MW5041578
• Device Sequence Number: 1
• Product Code: FPA
• 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: 03/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2015
• 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: ONGUARD
• Device Lot Number: M5308D14
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Treatment: FAMOTIDINE 20MG IVP; ACETAMINOPHEN 1000MG PO; RITUXAN 670MG IVPB X1; TREANDA (BENDAMUSTINE) 160MG IVPB X2 DAYS; PT RECEIVED DIPHENHYDRAMINE 50MG INJECT; GRANISETRON 664MCG+ DEXAMETHASONE 20MG IBPB; DEXAMETHASONE 20MG IVPB X1; X1 ALOXI 0.25MG IVP X1
• Patient Age: 61 YR
• Patient Weight: 67