MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. J CONNECTOR LOOP; INTRAVENOUS ADAPTER

Model Number	385121
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.(b)(4).
Event or Problem Description
It was reported that the j connector loop experienced an extension set that was loose/separated/detached.The following information was provided by the initial reporter: j loop pops out of cannula - isn't secure.New policy mandating use of j loops.When filming new procedure noted that jloops pop out of cannula as they are luer slip.This has been ongoing for a long time and reason they are not being used frequently.
Additional Manufacturer Narrative
H.6.Investigation: a device history record review was performed for provided lot number 9175189 and the review did not reveal any detected quality issues during the production process that could have contributed to this reported incident.To aid in the investigation of this issue, two samples were returned for evaluation by our quality engineer team.Through examination of the samples, the product appears to be in good condition.The samples were functionally tested and no issues with connection compatibility were identified.At this time, an exact cause related to the manufacturing process cannot be determined for this incident.
Event or Problem Description
It was reported that the j connector loop experienced an extension set that was loose/separated/detached.The following information was provided by the initial reporter: j loop pops out of cannula - isn't secure.New policy mandating use of j loops.When filming new procedure noted that jloops pop out of cannula as they are luer slip.This has been ongoing for a long time and reason they are not being used frequently.

• Brand Name: J CONNECTOR LOOP
• Common Device Name: INTRAVENOUS ADAPTER
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• MDR Report Key: 10857180
• Report Number: 9610847-2020-00361
• Device Sequence Number: 3253842
• Product Code: FPA
• UDI-Device Identifier: 30382903851219
• UDI-Public: 30382903851219
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: NA
• 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): 12/29/2020

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: Other
• Device Model Number: 385121
• Device Catalogue Number: 385121
• 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: 10/22/2020
• Supplement Date Received by Manufacturer: 12/29/2020
• Initial Report FDA Received Date: 11/17/2020
• Supplement Report FDA Received Date: 01/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1