MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. TRI-EXT SET 15CM SMALL BORE SPIN NUT; INTRAVASCULAR ADMINISTRATION SET

Model Number	385164
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that tri-ext set 15cm small bore spin nut was missing locking clamp.This was discovered before use.The following information was provided by the initial reporter: 1 lumen is missing a white locking clamp.
Additional Manufacturer Narrative
H.6.Investigation: a device history record review was performed for provided lot number 8148578 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, one picture sample was returned for evaluation by our quality engineer team.It appears that a physical sample was in the process of being returned for investigation; however, the sample is currently stuck in transit.The investigation was completed based on the provided picture sample.If the physical samples becomes available, this issue will be re-investigated if determined necessary.Through examination of the picture sample, the clamp component was observed missing from one lumen.It has been determined that this incident resulted from an error in the manufacturing facility of the supplier company.The components in question are received by bd from a supplier company.In response to this incident, a notification has been sent to the supplier and all applicable personnel have been informed of this incident for further awareness.
Event or Problem Description
It was reported that tri-ext set 15cm small bore spin nut was missing locking clamp.This was discovered before use.The following information was provided by the initial reporter: 1 lumen is missing a white locking clamp.

• Brand Name: TRI-EXT SET 15CM SMALL 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: 10135864
• Report Number: 9610847-2020-00176
• Device Sequence Number: 2240870
• Product Code: FPA
• UDI-Device Identifier: 50382903851640
• UDI-Public: 50382903851640
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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): 09/09/2020

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: 05/31/2021
• Device Model Number: 385164
• Device Catalogue Number: 385164
• Device Lot Number: 8148578
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/20/2020
• Supplement Date Received by Manufacturer: 05/20/2020
• Initial Report FDA Received Date: 06/09/2020
• Supplement Report FDA Received Date: 09/09/2020
• 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