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

Catalog Number	20129E
Medical Device Problem Code	Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
It was reported that bd alaris extension set was difficult to disconnect the following information was received by the initial reporter with the following.Reported issue per customer: pt pump alarming occluded, when trying to detach, blue nad would not separate from lipid filter.Reply: the event date is 02/19/24,.
Event or Problem Description
No additional information was provided.Material#: 20129e, batch number#: unknown.It was reported by customer that pt pump alarming occluded, when trying to detach, blue nad would not separate from lipid filter.Verbatim#: rcc received a complaint via email.Email(s) attached.Injuries or adverse event: no.Medline reference #: (b)(4).Item: 20129e: quantity affected: 1 ea.Serial/lot number: na.Po #: 4516935508.Are any samples available for return? yes.Reported issue per customer: pt pump alarming occluded, when trying to detach, blue nad would not separate from lipid filter.Reply: the event date is 02/19/24.
Additional Manufacturer Narrative
It was reported by customer that when trying to detach the blue nad connector, it would not separate from lipid filter.One sample model 20129e extension set with an unknown blue connector attached, was returned for investigation.The set was examined for defects and abnormalities.No defects or abnormalities were observed.The set was attached to a bd primary set and primed with 85% glycerin / 15% water.An infusion run was started at a rate of 1 ml/hr for 24 hrs.There was no observation of fluid blockage.The set was also tested with and without the unknown blue connector that was submitted with the sample.There were no issues with connecting and disconnecting the blue connector to the extension set.The customer complaint was unable to be replicated.A root cause was not determined because the reported failure was not replicated.A device history record review could not be performed because a lot number was not provided by the customer.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.

• Brand Name: BD ALARIS EXTENSION 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18891847
• Report Number: 9616066-2024-00416
• Device Sequence Number: 20709154
• Product Code: FPA
• UDI-Device Identifier: 50885403234901
• UDI-Public: (01)50885403234901
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K790108
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2024

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: 20129E
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2024
• Supplement Date Received by Manufacturer: 05/01/2024
• Initial Report FDA Received Date: 03/12/2024
• Supplement Report FDA Received Date: 05/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown