MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS S.A. DE C.V. BD SET XTN .4ML 9.5IN IV NDL FREE CONN SMALLBORE SPN M LL; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	20019E
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.B3.The date received by manufacturer has been used for this field.E1.Address information was not provided, therefore, xx was used as a place holder.
Event or Problem Description
It was reported that bd set xtn.4ml 9.5in iv ndl free conn smallbore spn m ll line occluded.The following information was provided by the initial reporter: nurse attempted to flush both needleless connector ports.One side flushed as it should.The other side was unable to be flushed, as if something was obstructing it.
Event or Problem Description
No additional info.
Additional Manufacturer Narrative
No product or photo was returned by the customer.The customer complaint that one side was unable to be flushed could not be verified due to the product not being returned for failure investigation.A device history record review for model 20019e lot number 23115175 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 23nov2023.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.

• Brand Name: BD SET XTN .4ML 9.5IN IV NDL FREE CONN SMALLBORE SPN M LL
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18827873
• Report Number: 9616066-2024-00351
• Device Sequence Number: 7935418
• Product Code: FPA
• UDI-Device Identifier: 27613203013813
• UDI-Public: (01)27613203013813
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K061285
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2024

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: Health Professional
• Device Catalogue Number: 20019E
• Device Lot Number: 23115175
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2024
• Supplement Date Received by Manufacturer: 04/12/2024
• Initial Report FDA Received Date: 03/04/2024
• Supplement Report FDA Received Date: 04/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/09/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown