MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. FILTERFLOW®; SET, ADMINISTRATION, INTRA

Catalog Number	473036
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).The device involved has not 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 or Problem Description
As reported by the user facility: during chemotherapy with ifosfamide, the filter was connected to the end of the primary administration set and the needle free valve/injection cap on the picc line.The filter did not disconnect but broke between the straight part and the circle of the filter.The straight part of the filter remained attached to the injection cap/valve after it broke.The filter did not leak prior to or end of infusion and filter did not appear cracked.After the chemotherapy was completed and the flush was infusing, the nurse believes there was no chemo loss or leakage, but precautions were taken just in case.Immediate medical intervention chemo spill kit was used, patient's arm was washed with soap and water.No injury reported.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).One (1) used primary set spike on nacl and one secondary set spiked on chemo was returned for evaluation.At the distal end of the primary set was the filter which was connected to a valve.At visual examination it was noted that the male luer of the filter was cracked off into the valve.Once the filter was removed from the primary set it was also noted that the female luer was severely cracked.The defect of leakage/cracks was confirmed through visual inspection.Although the defect of leakage was confirmed on the filter, the exact root cause of the cracks was not able to be determined at this time.The manufacturer reviewed the process and lot information and determined that this is not a manufacturing defect.Review of the discrepancy management system database performed for the reported lot number did not reveal any abnormalities or non-conformances of this nature.We will maintain this report for further references and continue to monitor other reports for similar occurrences.

• Brand Name: FILTERFLOW®
• Common Device Name: SET, ADMINISTRATION, INTRA
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd.; allentown PA 18109
• MDR Report Key: 7295660
• Report Number: 2523676-2018-00008
• Device Sequence Number: 14028576
• Product Code: FPA
• UDI-Device Identifier: 04022495770196
• UDI-Public: 04022495770196
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K942988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2022
• Device Catalogue Number: 473036
• Device Lot Number: 0061573924
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/30/2018
• Supplement Date Received by Manufacturer: 01/30/2018
• Initial Report FDA Received Date: 02/26/2018
• Supplement Report FDA Received Date: 04/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR