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	12/05/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The investigation into this reported event is ongoing.A follow-up report will be submitted when the results of the investigation are available.
Event or Problem Description
As reported by the user facility: patient was running around in the playroom which caused the tubing to be twisted and the connection to be over torqued, causing it to break and blood to leak.The patient's chemotherapy with mannitol was completed, so only primary fluids were running.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).One (1) used and one (1) unused sample, in packaging, were returned for evaluation.Upon visual inspection, the used sample was noted to be broken at the male luer.The unused sample was leakage tested, per specification, with passing results.The reported defect was confirmed on the used sample through visual inspection.Review of the discrepancy management system (dsms) database performed for the reported lot number revealed no abnormalities or non conformances noted during in process or final product inspection.Although the defect was confirmed, it should be noted that the patient was running around in the playroom causing the tubing to become twisted which over torqued the connection.We will maintain this report for further references and continue to monitor other reports for similar occurrences.If a sample and/or any additional pertinent information becomes available, a follow up will be submitted.

• 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: 7135366
• Report Number: 2523676-2017-00171
• Device Sequence Number: 1091398
• Product Code: FPA
• UDI-Device Identifier: 04022495770196
• UDI-Public: 4022495770196
• 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): 12/20/2017

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: 06/30/2022
• Device Catalogue Number: 473036
• Device Lot Number: 0061571397
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/05/2017
• Supplement Date Received by Manufacturer: 12/05/2017
• Initial Report FDA Received Date: 12/20/2017
• Supplement Report FDA Received Date: 01/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 18 MO