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

Model Number	30873
Medical Device Problem Codes	Leak/Splash (1354); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using bd alaris pca administration set the tubing was broken and leakage occurred.There was no report of patient impact.The following information was provided by the initial reporter: rns notified that pca tubing appeared to be broken.Upon inspection, luer lock part of tubing was still attached to patient iv, and tubing had broken just before luer lock junction.Rns had to prime new tubing set, and waste medication.1.8ml (3.6mg) of concentrated hydromorphone wasted.
Additional Manufacturer Narrative
Date of event is unknown; awareness date has been used for this field.Medical device expiration date: unknown.Device manufacture date: unknown.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 bd alaris pca administration set the tubing was broken and leakage occurred.There was no report of patient impact.The following information was provided by the initial reporter: rns notified that pca tubing appeared to be broken.Upon inspection, luer lock part of tubing was still attached to patient iv, and tubing had broken just before luer lock junction.Rns had to prime new tubing set, and waste medication.1.8ml (3.6mg) of concentrated hydromorphone wasted.
Additional Manufacturer Narrative
H6: investigation summary one sample was received for quality investigation.The customer complaint of component damage was verified by visual inspection.Evaluation of the sample submitted shows that the male luer connector was damaged and missing the securement collar.The male luer connector body was broken in half without any indication of bending of the body material, which indicates that a strong force was applied, causing it to break.A device history record review could not be performed because the lot number is unknown.The root cause of the issue seen in this complaint is an issue with connecting / disconnecting the luer adapter, or misue of the luer connector.Similar breaks in the male luer adapter have been seen when applying a large amount of force perpendicular to the longitudinal axis of the luer adapter when connecting or disconnecting the luer.This force causes the luer to break as shown in the returned sample.This force can be introduced on the sample when connecting/disconnecting the sample or if the luer gets caught on something and the tubing pulled hard enough to break the luer.

• Brand Name: BD ALARIS PCA ADMINISTRATION 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: 15929205
• Report Number: 9616066-2022-01880
• Device Sequence Number: 6563347
• Product Code: FPA
• UDI-Device Identifier: 50885403273948
• UDI-Public: (01)50885403273948
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K811885
• 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): 12/09/2022

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 Model Number: 30873
• Device Catalogue Number: 30873
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2022
• Supplement Date Received by Manufacturer: 12/09/2022
• Initial Report FDA Received Date: 12/06/2022
• Supplement Report FDA Received Date: 12/23/2022
• 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