MAUDE Adverse Event Report: B. BRAUN DOMINICAN REPUBLIC INC. BLOOD ADMINISTRATION SET; SET, ADMINISTRATION, INTRA

Catalog Number	490314
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Although the device involved was confirmed not to be available for evaluation; a photo was provided 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: event 6: it was reported that the set leaked during use with lactated ringers and/or normal saline.No patient injury reported.
Additional Manufacturer Narrative
Event 6: this report has been identified as b.Braun medical internal report number (b)(4).No actual samples were returned.Although a picture was attached it did not clearly confirm the leakage at the blood filter area.The reported defect was unable to be confirmed.The retain samples were tested for leakage per specification and no defects were found.Without the actual device a thorough investigation could not be performed.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.If the sample and/or any additional pertinent information becomes available the complaint will be re-opened.
Additional Manufacturer Narrative
Event 6: this report has been identified as b.Braun medical internal report number (b)(4).Ten (10) used samples with no packaging were returned for evaluation.All returned product was tested for leakage per specification and all ten set failed.Leakage was observed at the bonded joint between the tubing and top cap of the blood filter housing.All ten samples were functionally tested and confirmed the reported defect of leakage at the bonded joint of the drip chamber.Incidents of this nature are attributed to operator oversight during the manual assembly of the product.Although our training procedures ensure that all of our employees are properly trained in their areas of responsibility, an oversight on the part of the operator can attribute to an incident of this nature.All available information regarding this occurrence has been forwarded to our mrb business unit leaders and all personnel involved in the manufacturing and inspection of this product in order to heighten awareness.We will maintain this report for further references and continue to monitor other reports for similar occurrences.Review of the discrepancy management system database performed for the reported lot number did not reveal any abnormalities or non-conformances of this nature.

• Brand Name: BLOOD ADMINISTRATION SET
• Common Device Name: SET, ADMINISTRATION, INTRA
• Manufacturer (Section D): B. BRAUN DOMINICAN REPUBLIC INC.; las americas industrial park; km22 autopista las americas; santo domingo, ; DR
• MDR Report Key: 7275050
• Report Number: 9614279-2018-00043
• Device Sequence Number: 1043977
• Product Code: FPA
• UDI-Device Identifier: 04046964527180
• UDI-Public: 04046964527180
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K083723
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/09/2018

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: 09/30/2020
• Device Catalogue Number: 490314
• Device Lot Number: 0061587508
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/30/2018
• Supplement Date Received by Manufacturer: 03/30/2018; 03/30/2018
• Initial Report FDA Received Date: 02/15/2018
• Supplement Report FDA Received Date: 03/09/2018; 05/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1