MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD ALARIS¿ SMARTSITE¿ GRAVITY SET; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	42519E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/16/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd alaris¿ smartsite¿ gravity set leaked at the connection between the tubing and manifold.The following information was provided by the initial reporter: it was brought to my attention that a provider found bd iv gravity tubing set (42519e) leaking at the point of contact between the tubing and the manifold.Additionally, within the same lot number we found multiple iv tubing sets to have been manufactured poorly at the same contact point.
Additional Manufacturer Narrative
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 the bd alaris¿ smartsite¿ gravity set leaked at the connection between the tubing and manifold.The following information was provided by the initial reporter: "it was brought to my attention that a provider found bd iv gravity tubing set (42519e) leaking at the point of contact between the tubing and the manifold.Additionally, within the same lot number we found multiple iv tubing sets to have been manufactured poorly at the same contact point.".
Additional Manufacturer Narrative
H6: investigation summary the customer reported leaking where the tubing connects, and returned two used sets, one unopened set, and a photo of material 42519e.The two used sets both had issues, but only one was leakage.The second used set had a deformed and bent male luer post coming out of the out of the stop cock.The first set also had an issue at the stopcock, just at the inlet.The tubing was torn and had a hole at the solvent connection, verifying the leak.Surprisingly, the second used set with the deformed post did not leak.The issue appeared to only be cosmetic, there is a video of the tubing working fine.The unused tubing had no observed failures and worked fine.The leaking tubing also had a defective clamp on the tubing after the stopcock.Manufacturing only found fault with the stopcock inlet, where it was found that improper use of the expander caused the failure.Quality alert issued to personnel on proper use of the expander.Device history record review for model 42519e lot number 2202974 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 28feb2022.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.

• Brand Name: BD ALARIS¿ SMARTSITE¿ GRAVITY SET
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15405553
• Report Number: 9616066-2022-01312
• Device Sequence Number: 6952251
• Product Code: FPA
• UDI-Device Identifier: 07613203010870
• UDI-Public: 07613203010870
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K931173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2022

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 Catalogue Number: 42519E
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2022
• Supplement Date Received by Manufacturer: 11/09/2022
• Initial Report FDA Received Date: 09/12/2022
• Supplement Report FDA Received Date: 11/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown