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

Catalog Number	354218
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).One (1) used sample was returned for evaluation.The returned product was functionally tested and confirmed the reported defect of leakage at the top cap of the blood filter housing.The sample and all available information regarding this complaint was forwarded to filtertek, the supplier of the housing.As per the supplier's investigation, the defect was confirmed.The supplier evaluated the returned sample and observed leakage at the housing area.Due to this complaint and other complaints similar in nature, filtertek has implemented a new electronic solvent dispenser to assure better solvent application on the bonded joint area.In addition, the number of pieces for the destructive leak testing has been increased from (1) piece every four hours to (3) pieces every four hours.A review of the discrepancy management system (dsms) database was unable to be performed as the lot number was reported as unknown.We will maintain this report for further references and continue to monitor other reports for similar occurrences.This case is being filed retrospectively as a result of a review of recent customer complaint information.Based on a new complaint case and an updated procedure, it was determined that this case is reportable in accordance with the requirements of 21 cfr 803.B.Braun has conducted a retrospective review for all complaints of similar nature in accordance with b.Braun internal procedures.
Event or Problem Description
As reported by the user facility: leaking occurred during use.No patient injury.Limited information provided.

• 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: 7274184
• Report Number: 9614279-2018-00029
• Device Sequence Number: 1133402
• Product Code: FPA
• UDI-Device Identifier: 04046964182310
• UDI-Public: 04046964182310
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K083723
• 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
• Report Date (Section B): 02/15/2018

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 Catalogue Number: 354218
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2016
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/07/2016
• Initial Report FDA Received Date: 02/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1