MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD¿ J CONNECTOR LOOP WITH FLEXIBLE EXTENSION TUBING; J-LOOP CONNECTOR

Catalog Number	385121
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that leakage occurred from the connection between the bd¿ j connector loop with flexible extension tubing and the reflux valve.There was no report of exposure, injury, or medical intervention.
Additional Manufacturer Narrative
Investigation summary: a device history report was conducted for lot number 7327648.During our review no abnormalities related to this event were found during our monitoring of the manufacturing process.According to our records this lot of j loop luer slip was manufactured 12/20/2017, and this is the only instance of leakage occurring in this lot.According to the sampling plan applied for product performance, this lot was accepted and released, with no defects being noted during final assembly or in packaging visual inspections.A sample and photograph were submitted by your facility for evaluation and testing.Although the photograph shows the reported failure mode occurring, no abnormalities could be identified in the returned sample despite attempts to identify the cause using leakage testing and microscopic evaluation of the device.A possible explanation for this phenomena is the sterilization process of all potentially contaminated devices.The high heat of this process is sufficient to result in the deformation of the septum, potentially sealing any openings that would allow the passage of fluid.Based on investigation results to date, root cause for manufacturing process cannot be determined.Bd will continue to track and trend for this issue.In case any emerging trend is detected, further actions will be taken if necessary.Based on an evaluation of severity and frequency it was determined that no corrective action is required at this time.
Event or Problem Description
It was reported that leakage occurred from the connection between the bd¿ j connector loop with flexible extension tubing and the reflux valve.There was no report of exposure, injury, or medical intervention.

• Brand Name: BD¿ J CONNECTOR LOOP WITH FLEXIBLE EXTENSION TUBING
• Common Device Name: J-LOOP CONNECTOR
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales
• MDR Report Key: 7930669
• Report Number: 9610847-2018-00316
• Device Sequence Number: 1513910
• Product Code: JKA
• UDI-Device Identifier: 30382903851219
• UDI-Public: 30382903851219
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2018

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: 11/30/2022
• Device Catalogue Number: 385121
• Device Lot Number: 7327648
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2018
• Initial Date Received by Manufacturer: 09/11/2018
• Supplement Date Received by Manufacturer: 09/11/2018
• Initial Report FDA Received Date: 10/03/2018
• Supplement Report FDA Received Date: 11/13/2018
• 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