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

Catalog Number	471950
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	07/10/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device involved has been received for evaluation 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: customer reports, "leakage from the connection with the infusion line had occurred.A crack was observed at the female adaptor." although there was blood leakage from the connection of the tubing, there was no adverse reaction to the baby.The extension set in question was immediately replaced with a brand new one, and the infusion was continued all right.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).One (1) used smallbore set (with packaging) connected at the female adapter to an unknown set was returned for evaluation.Visual examination of the smallbore set noted the green female adapter to be cracked.No other visual defects were noted.The smallbore set was pressure tested per specification with failing results as leakage was found at the location of the green female adapter crack.The returned smallbore set confirmed the reported complaint leakage.Although the reported defect was confirmed, no specific conclusions can be made regarding the cause of the reported event.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-conformance of this nature.

• 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: 6798967
• Report Number: 2523676-2017-00111
• Device Sequence Number: 1002785
• Product Code: FPA
• UDI-Device Identifier: 04022495770080
• UDI-Public: 04022495770080
• 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,Followup
• Report Date (Section B): 07/18/2017

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: 12/31/2021
• Device Catalogue Number: 471950
• Device Lot Number: 0061539334
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/18/2017
• Supplement Date Received by Manufacturer: 07/18/2017
• Initial Report FDA Received Date: 08/16/2017
• Supplement Report FDA Received Date: 10/16/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 2 MO