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	02/05/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device involved has not 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: the product in question was used for arterial blood sampling line.Upon connecting the product to the arterial line, there was blood leakage from the product.Because the patient was in nicu and was in critical condition, fluid administration was considered for the blood loss.
Additional Manufacturer Narrative
(b)(4).One (1) used set without packaging, two (2) unopened blisters, and one (1) used 6ml luer slip terumo syringe without packaging was returned for evaluation.Visual examination of the sets noted the green luer adapter to be cracked on the used set.No other visual defects were noted.The sets were pressure tested per specification.The 2 unused sets passed the test, and the used set failed the test with leakage noted at the crack on green luer adapter.The terumo syringe was checked per iso standard, and found to meet the iso standard.In order to replicate the reported event, the terumo syringe was filled to 5ml with water.Then the syringe was inserted and injected into each green luer adapter of both unused sets 3 times.No issues were noted.The used set confirmed the reported defect of cracked/leaking set.Review of the discrepancy management system database performed for the reported lot number did not reveal any abnormalities or non-conformances of this nature.Five (5) retain samples were visually examined per specification with passing results.In addition, the retain samples were occlusion and leakage tested per specification with passing results.The retains met specifications.Based on the results of the sample evaluation, 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.

• 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: 7295694
• Report Number: 2523676-2018-00009
• Device Sequence Number: 1211725
• 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,Followup
• Report Date (Section B): 03/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2021
• Device Catalogue Number: 471954
• Device Lot Number: 0061541400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/05/2018
• Supplement Date Received by Manufacturer: 02/05/2018
• Initial Report FDA Received Date: 02/26/2018
• Supplement Report FDA Received Date: 03/23/2018
• 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: Other