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

Catalog Number	42100E-07
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/29/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Therefore, bd corporate headquarters in franklin lakes, nj has been listed in sections d.3.And g.1.And the franklin lakes fda registration number has been used for the manufacture report number.D.4.Medical device expiration date: unknown.H.4.Device manufacture date: unknown.B.3.Date of event is unknown; awareness date has been used for this field.H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported while using unspecified bd extension set the connection came apart and leakage occurred.There was no report of patient impact.The following information was provided by the initial reporter: issue reported by rn.Many times they have a problem with the connections coming loose, falling to the floor and resulting in contamination of the tubing and blood coming backwards and pouring out of the iv.The nurses in their unit, including her have noticed this for as long as they have been using it and she has been there for 6 years.She is not sure if the issues prior have been reported and states that it seems to be an issue with how the product is manufactured.The connection is either loose right out of the package or becomes loose very easily where the tubing connects at the site of the valves.Unsure if they have the exact product used to return for evaluation.
Event or Problem Description
New information added- manufacturer location and product name mat#: 42100e-07 lot#: 22099430.It was reported by customer that connections coming loose, falling to the floor and resulting in contamination of the tubing and blood coming backwards and pouring out of the iv.Verbatim: complaint received via phone.Pir attached.Product complaint: xxx.42100e-07.Lot number is (10)22099430.Issue reported by rn.Many times they have a problem with the connections coming loose, falling to the floor and resulting in contamination of the tubing and blood coming backwards and pouring out of the iv.The nurses in their unit, including her have noticed this for as long as they have been using it and she has been there for 6years.She is not sure if the issues prior have been reported and states that it seems to be an issue with how the product is manufactured.The connection is either loose right out of the package or becomes loose very easily where the tubing connects at the site of the valves.Unsure if they have the exact product used to return for evaluation.
Additional Manufacturer Narrative
Additional information received - manufacturer location updated and product name investigation results: no product or photo was returned by the customer.The customer complaint of separation other component - leak could not be verified due to the product not being returned for failure investigation.A device history record review for material# 42100e-07 and lot# 22099430 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 29sep2022.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Due to no sample being received, an investigation could not be performed, and a root cause could not be determined.This incident has been added to our database of reported incidents.

• 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 NJ 22244
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana NJ 22244
• Manufacturer Contact: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17927854
• Report Number: 2243072-2023-01845
• Device Sequence Number: 6435408
• Product Code: FPA
• UDI-Device Identifier: 50885403220607
• UDI-Public: (01)50885403220607
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K820278
• 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): 01/22/2024

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: 42100E-07
• Device Lot Number: 22099430
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2023
• Supplement Date Received by Manufacturer: 01/22/2024
• Initial Report FDA Received Date: 10/12/2023
• Supplement Report FDA Received Date: 02/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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