MAUDE Adverse Event Report: B. BRAUN MEDICAL ASPIRATION/INJECTION DISK FILTER

Model Number PF5000

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Information (3190)

Event Type  Injury  

Event Description

Integrity of a 5 micrometer disk filter compromised.Iv tech noticed a large particle after filtration.Discarded syringe with product.Manufacturer: pall medical.

• Brand Name: ASPIRATION/INJECTION DISK FILTER
• Type of Device: ASPIRATION/INJECTION DISK FILTER
• Manufacturer (Section D): B. BRAUN MEDICAL
• MDR Report Key: 5201362
• MDR Text Key: 30477816
• Report Number: MW5057660
• Device Sequence Number: 1
• Product Code: FPB
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2017
• Device Model Number: PF5000
• Device Lot Number: 12464161
• Is the Reporter a Health Professional?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention