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

Model Number	10800175
Medical Device Problem Codes	Leak/Splash (1354); Material Perforation (2205)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/25/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using bd alaris¿ pca kit asv microbore cv there was component damage and leakage occurred.There was no report of patient impact.The following information was provided by the initial reporter: material#: 10800175 batch#: unknown it was reported by customer that additional leakage happened on (b)(6) 2023, (b)(6) 2023.Customer stayed that there is holes in tubing described as micro-punctures.There were no adverse events/injuries.Verbatim: additional info received on pr(b)(4) tubing defective and leakage ¿ date of incident: (b)(6) 2023.1.Was there any patient involvement? if yes, what is the patient outcome? is there any adverse event/serious injury? a.Yes, three patients involved.All three patients are out of icu and on step-down units, still admitted to the hospital.There were no adverse events/injuries.2.Was there any exposure towards the patient or healthcare worker? a.No known exposure.3.How many occurrences of the defective item? a.Three separate occurrences.Leakage ¿ (past two months) are you able to provide date of incident for event in the format of dd-mm-yyyy? a.(b)(6) 2023 2.Was there any noticeable crack or hole that caused leakage for the incident within the past two months? a.Holes in tubing described as micro-punctures.3.Was there any patient involvement? if yes, what is the patient outcome? is there any adverse event/serious injury? a.See question 1 above.4.How many occurrences of the defective item? a.See question 3 above.Customer reported the leakage - (past two months) doe: (b)(6) 2023.Verbatim on pr# (b)(4).Rn witnessed pooling pca medication on the floor of sicu 401.Upon inspection, medication was "seeping" out from pca iv tubing and onto the floor along the entire length of the tubing.No evidence of external tampering with pca iv tubing, but rather defective or improperly manufactured tubing as evidenced by the microscopic holes that run along the full length of the tubing.Unit manager notified.Call placed to pharmacy to inquire about other instances of defective tubing, pharmacy tech had not heard anything and encouraged rn to call central supply.Rn placed call to central supply, and supply employee was unaware of any defective tubing.*of note: within the past 2 months, there have been at least 2 other instances on sicu of pca iv tubing needing to be changed due to medication leaking onto the floor.These instances were undocumented as they were thought to be coincidence, however now seem to be evidence of a larger supply issue.
Additional Manufacturer Narrative
D.4.Medical device expiration date: unknown.H.4.Device manufacture date: unknown.H6: investigation summary a complaint of set having microholes causing leakage was received from the customer.A video was provided by the customer where the tubing is seen to be leaking.The customer complaint of component damage - leak was confirmed.A device history record review could not be performed on model 10900175 because the lot number is unknown.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.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text : see h.10.

• Brand Name: BD ALARIS¿ PCA KIT ASV MICROBORE CV
• 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 ; 8448235433
• MDR Report Key: 17198847
• Report Number: 9616066-2023-01250
• Device Sequence Number: 17538089
• Product Code: FPA
• UDI-Device Identifier: 10885403234408
• UDI-Public: (01)10885403234408
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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
• Report Date (Section B): 06/08/2023

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: 10800175
• Device Catalogue Number: 10800175
• Device Lot Number: UNKNOWN
• 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: 05/30/2023
• Initial Report FDA Received Date: 06/26/2023
• 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