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

Catalog Number	471954
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	02/15/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Ten (10) of the received samples from lot # 0061555072 were visually examined per specification with no defects noted.These ten (10) samples were occlusion and leakage tested per specification with passing results.The returned unused sets did not confirm the reported defect of leakage.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.
Event or Problem Description
While administering the electrolyte solution to a nicu patient, the nurse found that the female luer was cracked causing about 5 ml of blood to leak.

• Brand Name: EXTENSION SET
• Common Device Name: SET, ADMINISTRATION, INTRA
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd.; allentown PA 18109
• MDR Report Key: 7393625
• Report Number: 2523676-2018-00018
• Device Sequence Number: 11035882
• Product Code: FPA
• UDI-Device Identifier: 04022495770103
• UDI-Public: 04022495770103
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K942988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 04/03/2018

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: 02/28/2022
• Device Catalogue Number: 471954
• Device Lot Number: 0061555072
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2018
• Initial Report FDA Received Date: 04/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 2