MAUDE Adverse Event Report: 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	09/04/2018
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.It should be noted that the end user has three (3) possible batch numbers in stock; however, it is unsure which batch number was used.The possible batch numbers are: batch number: 0061557821, production date: 04/06/2017, expiry date: 03/31/2022.Batch number: 0061572674, production date: 07/20/2017, expiry date: 06/30/2022.Batch number: 0061582893, production date: 09/22/2017, expiry date: 08/31/2022.
Event or Problem Description
As reported by the user facility: event 2: end user reports that a crack was found at around the female luer, and blood leakage was noted.No injuries reported.
Additional Manufacturer Narrative
Event 2: this report has been identified as b.Braun medical internal report number (b)(4).Two (2) used sets without packaging and one (1) terumo luer slip syringe without packaging were returned for evaluation.Visual examination of the sets noted 1 vertical crack on the green female luer adapter.No other visual defects were noted.The sets were pressure tested per specification with failing results as leakage was noted at the location of the crack on each set.The returned sets confirmed the reported defect of leakage.The exact root cause could not be determined at this time.However, incidents of cracked/leaking valves can be caused by several factors, including but not limited to the product being subjected to aggressive solvents/drugs, excessive mechanical stresses (over-tightening), or other various unforeseen circumstances during the clinical application.A review of the discrepancy management system (dsms) database was performed for the reported possible lot numbers and no abnormalities or non-conformances were noted during the in process or final product inspection.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: EXTENSION SET
• Common Device Name: SET, ADMINISTRATION, INTRA
• MDR Report Key: 7929534
• Report Number: 9614279-2018-00165
• Device Sequence Number: 2270045
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2018

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 Catalogue Number: 471954
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2018
• Initial Date Received by Manufacturer: 09/05/2018
• Supplement Date Received by Manufacturer: 09/05/2018
• Initial Report FDA Received Date: 10/03/2018
• Supplement Report FDA Received Date: 10/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1