MAUDE Adverse Event Report: B. BRAUN MELSUNGEN AG PF2000; FILTER .2 MICRON

Catalog Number 415002

Device Problems Failure to Deliver (2338); No Flow (2991)

Patient Problem Patient Problem/Medical Problem (2688)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device involved has been received for evaluation and the investigation is ongoing at this time.A follow up will be submitted when the investigation results become available.

Event Description

As reported by the user facility: event: no flow with several filters after iv line primed, also had occurrences during infusion that there was no flow.No samples of used product.Will retain 1 sterile sample.No patient injury reported.

Manufacturer Narrative

(b)(4).Five (5) unused samples were tested using bubble point and liquid flow rate test, and based on the testing results, the filters passed the required specifications during testing.The lot history records were reviewed for the reported lot number 12840647, and confirmed to have been manufactured and released according to specifications meeting all quality control requirements with no deviations detected.If any additional pertinent information becomes available, a follow up will be submitted.

• Brand Name: PF2000
• Type of Device: FILTER .2 MICRON
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl-braun str.1; melsungen, 34212 ; GM 34212
• Manufacturer (Section G): B. BRAUN MELSUNGEN AG; carl-braun str.1; melsungen, 34212 ; GM 34212
• Manufacturer Contact: ludwig schuetz ; b. braun melsungen ag; carl-braun str. 1; melsungen, 34212 ; GM 34212 ; 661712769
• MDR Report Key: 5967569
• MDR Text Key: 55325800
• Report Number: 9610825-2016-00615
• Device Sequence Number: 1
• Product Code: FPB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K941589
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/01/2016,09/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2019
• Device Catalogue Number: 415002
• Device Lot Number: 12840647
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2016
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/01/2016
• Distributor Facility Aware Date: 09/06/2016
• Event Location: Hospital
• Date Report to Manufacturer: 11/01/2016
• Date Manufacturer Received: 09/06/2016
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1