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

Catalog Number	490453
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
This report has been identified as (b)(4).One (1) sample, in open packaging, was returned for evaluation.Visual examination noted the ball lodged between the tubing dispensed and roam freely in the tubing.A leakage test was performed per specification and leakage was found from the blood filter.All information of this incident was forwarded to our supplier for evaluation.Our supplier performed an investigation, but could not determine the exact root cause into the incident.However, since the production of the lot, they have added a new electronic solvent dispenser to assure better solvent application to the bonded area.In addition, the supplier has also increased their in-process inspection sample size to improve detection of defects.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.Note: 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: end user reports that the iv tube cracked just below the filter aspect of the tubing, when clinician was using hand pump.Sodium chloride was used at the time of incident.No injuries to patient reported.

• 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: 7274446
• Report Number: 9614279-2018-00015
• Device Sequence Number: 1177437
• Product Code: FPA
• UDI-Device Identifier: 04046964848957
• UDI-Public: 04046964848957
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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 Expiration Date: 07/31/2019
• Device Catalogue Number: 490453
• Device Lot Number: 0061517190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2016
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2016
• 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
• Outcome Attributed to Adverse Event: Congenital Anomaly