MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. Y EXT SET 20CM MACRO BORE SPIN NUT; INTRAVASCULAR ADMINISTRATION SET

Model Number	385165
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/25/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that the y ext set 20cm macro bore spin nut leaked during use.The following information was provided by the initial reporter: "extension set leaked.".
Additional Manufacturer Narrative
H.6.Investigation summary: a device history record review was performed for provided lot number 9091629 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 incident, one picture sample was received for evaluation by our quality engineer team.Through examination of the picture, leakage was observed at the union of the tubing and the y component.At this time, a manufacturing related cause could not be identified for this incident.Our quality team will continue to monitor the production process for signs of this potential defect and any emerging trends.H3 other text : see h.10.
Event or Problem Description
It was reported that the y ext set 20cm macro bore spin nut leaked during use.The following information was provided by the initial reporter: "extension set leaked".

• Brand Name: Y EXT SET 20CM MACRO BORE SPIN NUT
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• MDR Report Key: 10165909
• Report Number: 9610847-2020-00181
• Device Sequence Number: 909116
• Product Code: FPA
• UDI-Device Identifier: 50382903851657
• UDI-Public: 50382903851657
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K142527
• 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): 07/01/2020

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 Expiration Date: 03/31/2022
• Device Model Number: 385165
• Device Catalogue Number: 385165
• Device Lot Number: 9091629
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/26/2020
• Supplement Date Received by Manufacturer: 05/26/2020
• Initial Report FDA Received Date: 06/17/2020
• Supplement Report FDA Received Date: 07/02/2020
• 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