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

Catalog Number	490355
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
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: an iv tubing set was leaking at the y port.No injury was reported.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).One (1) used sample with no packaging was returned for evaluation.The sample and available information was forwarded the manufacuture for further evaluation.Based on the evaluation results, the sample was tested for leakage with passing results.However, visually it was noted that coagulated blood was present between the bottom filter cap and the filter body at the bonded joint.The supplier confirmed that the defect of leakage is due to insufficient glue when adhering the molded ends to the tube.Per the suppliers statement, new visual and written instructions are currently in process.All operators involved with the assembly process, will be trained to this new procedure.We will maintain this report for further references and continue to monitor other reports for similar occurrences.If any additional pertinent information becomes available, a follow up will be submitted.

• Brand Name: BLOOD ADMINISTRATION SET
• Common Device Name: SET, ADMINISTRATION, INTRA
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd; allentown 18109
• MDR Report Key: 8571471
• Report Number: 9614279-2019-00070
• Device Sequence Number: 1667560
• Product Code: FPA
• UDI-Device Identifier: 04046964616013
• UDI-Public: 04046964616013
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: K083723
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2019

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: 09/30/2021
• Device Catalogue Number: 490355
• Device Lot Number: 0061643296
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/18/2019
• Supplement Date Received by Manufacturer: 04/18/2019
• Initial Report FDA Received Date: 05/01/2019
• Supplement Report FDA Received Date: 09/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: MW0800040000-2019-8024
• Patient Sequence Number: 1
• Patient Age: 39 YR