MAUDE Adverse Event Report: BLOOD ADMINISTRATION SET; STOPCOCK, I.V. SET

Catalog Number	490293
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).Although it was confirmed that the device involved is not available for evaluation, 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 that there is a leak from the top of the drip chamber.No injury reported.
Additional Manufacturer Narrative
No samples were returned for evaluation.However, a video was provided.The video confirmed the extension set to be leaking at the bonded joint between the tubing and the top of the blood filter housing.Therefore, the reported defect was confirmed.Review of the discrepancy management system (dsms) database performed for the reported lot number revealed no abnormalities or non-conformances noted during in process or final product inspection.Incidents of this nature are attributed to operator oversight during the manual assembly of the product.Although our training procedures ensure that all of our employees are properly trained in their areas of responsibility, an oversight on the part of the operator can attribute to an incident of this nature.No adverse quality trends of this nature were identified during the complaint review process for the reported catalog number.

• Brand Name: BLOOD ADMINISTRATION SET
• Common Device Name: STOPCOCK, I.V. SET
• MDR Report Key: 8461285
• Report Number: 9614279-2019-00042
• Device Sequence Number: 13847096
• Product Code: FMG
• UDI-Device Identifier: 04046964539657
• UDI-Public: 04046964539657
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2019

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: 490293
• Device Lot Number: 0061644174
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/04/2019
• Supplement Date Received by Manufacturer: 03/04/2019
• Initial Report FDA Received Date: 03/28/2019
• Supplement Report FDA Received Date: 04/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1