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

Catalog Number	11448964
Medical Device Problem Codes	Disconnection (1171); Separation Problem (4043)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3.The date received by manufacturer has been used for this field.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 secondary set separated the following information was received by the initial reporter with the verbatim reported details: record opened in relation to existing complaints related to luer lock disconnections.Sample was received as part of existing investigations and identified the luer may not be compatible with optima injector luer , it was detected that the dimensions of the connector of the iv-set do not comply with iso 80369-7:2021(e).Per initial report : line disconnected at secondary piggy back port.Etoposide running.Bd phaseal optima injector product #515052 luered off at end of secondary line.Resulted in opening system, loss of drug dose etoposide, and exposure to hazardous drug.
Additional Manufacturer Narrative
(b)(4): follow up mdr for device evaluation and correction.Annex codes a, e and f corrected.The customer reported the line disconnected and returned two samples to a bd facility in spain.The investigation there found the male luers to be out of compliance, verifying the complaint.The samples were then sent to the luer supplier for further investigation.This investigation was cut short because of the previous compliance testing had altered the luers, and no conclusion was made.The conclusion from the investigation is that without any previous issues of this type (supplier reported 35+ million of these components are supplied, without any other similar complaint) the issue cannot be officially confirmed.The root cause cannot be confirmed without the failure being confirmed.Potential cause is mis-threading of the luer.A device history record review could not be performed on material 11448964 because the lot number is unknown.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.Your assistance in this matter has been helpful in trend identification and supporting our commitment to continuous quality improvement.H3 other text : see h10 manufacture narrative.
Event or Problem Description
What is the date of event? january 2024.Please share the lot number.Not available.Describe any patient harm, injury, complication or negative outcome that occurred because of the event.There was no patient harm any sample available for investigation? if yes, are you able to provide the address of the facility for us to ship the return label? there is not a sample available for return please share the captured photo of the event if available.No photo available.

• Brand Name: BD ALARIS SECONDARY 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: 18652400
• Report Number: 9616066-2024-00186
• Device Sequence Number: 15515218
• Product Code: FPA
• UDI-Device Identifier: 50885403234741
• UDI-Public: (01)50885403234741
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K790582
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2024

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: 11448964
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2024
• Supplement Date Received by Manufacturer: 04/10/2024
• Initial Report FDA Received Date: 02/06/2024
• Supplement Report FDA Received Date: 04/15/2024
• 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