MAUDE Adverse Event Report: BECTON DICKINSON 60 IN ULTRA MINIBORE EXTENSION SET; INTRAVASCULAR ADMINISTRATION SET

Model Number	ME2017
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/25/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident, and without this information, we are unable to determine where the device was manufactured.Therefore, bd corporate headquarters in (b)(4) has been listed, and (b)(4) fda registration number has been used for the manufacture report number.Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.(b)(4).
Event or Problem Description
It was reported that a 60 in ultra mini-bore extension set experienced component separation, and leakage during use.The following was reported by the initial reporter: "it was reported that the center part of the tube broke off in the hub.This resulted in the tube leaking when disconnected.Verbatim: the center part of the tubing broke off in the hub of the septi-fuse, and when disconnected the ivf continually dripped out of the tubing.".
Event or Problem Description
It was reported that a 60 in ultra minibore extension set experienced component separation and leakage during use.The following was reported by the initial reporter: "it was reported that the center part of the tube broke off in the hub.This resulted in the tube leaking when disconnected.Verbatim: the center part of the tubing broke off in the hub of the septi-fuse, and when disconnected the ivf continually dripped out of the tubing".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.10.Device available for eval?: yes d.10.Returned to manufacturer on: 11/5/2020.H.6.Investigation: the customer reported that the center part of the tube broke off in the hub and returned the affected sample.The post of the male luer was broken off and the complaint is verified.The luer was observed under the microscope but the root cause could not be determined.A device history record review could not be performed on model me2017 because a lot number was not provided by the customer.H3 other text : see h.10.

• Brand Name: 60 IN ULTRA MINIBORE EXTENSION SET
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 10891584
• Report Number: 2243072-2020-01915
• Device Sequence Number: 11462948
• Product Code: FPA
• UDI-Device Identifier: 50885403236240
• UDI-Public: 50885403236240
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K051499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/24/2020

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 Model Number: ME2017
• Device Catalogue Number: ME2017
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2020
• Initial Date Received by Manufacturer: 10/28/2020
• Supplement Date Received by Manufacturer: 11/24/2020
• Initial Report FDA Received Date: 11/24/2020
• Supplement Report FDA Received Date: 12/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1