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

Model Number	30873
Medical Device Problem Codes	Crack (1135); Leak/Splash (1354)
Health Effect - Clinical Codes	Awareness during Anaesthesia (1707); No Consequences Or Impact To Patient (2199)
Date of Event	12/30/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: a complaint of a cracked component was received from the customer.No product or photo was returned by the customer.The customer complaint of cracked component could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed on model 30873 because a lot number was not provided by the customer.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.
Event or Problem Description
It was reported that 1 pca asv microbore cv in an unspecified lot, and 2 sets in another unspecified lot had cracks and leaked during use.The following information was provided by the initial reporter: "i¿m not sure if the pca admin tubing product rolls up to you or not, but we have had several incidents in the last 10 days or so where the pca tubing connector is cracked causing medication to leak from the tubing.".
Additional Manufacturer Narrative
Corrections: b.5.Describe event or problem: it was reported that 1 bd alaris¿ pca microbore tubing set in an unspecified lot, and 2 sets in another unspecified lot had cracks and leaked during use.D.1.Medical device brand name: bd alaris¿ pca microbore tubing set.H.1.Type of reportable events: serious injury.H.6.Imdrf annex e grid: e2102.H.6.Imdrf annex f grid: f1004, f2303.H.6.Imdrf annex a grid: a0404.Investigation: h.6.Investigation summary: a complaint of a cracked component was received from the customer.No product or photo was returned by the customer.The customer complaint of cracked component could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed on model 30873 because a lot number was not provided by the customer.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 section h10.
Event or Problem Description
It was reported that 1 bd alaris¿ pca microbore tubing set in an unspecified lot, and 2 sets in another unspecified lot had cracks and leaked during use.The following information was provided by the initial reporter: "i¿m not sure if the pca admin tubing product rolls up to you or not, but we have had several incidents in the last 10 days or so where the pca tubing connector is cracked causing medication to leak from the tubing.".

• Brand Name: BD ALARIS¿ PCA MICROBORE TUBING 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 22244 ; MX 22244
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana 22244 ; MX 22244
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 11206413
• Report Number: 9616066-2021-50086
• Device Sequence Number: 14578366
• Product Code: FPA
• UDI-Device Identifier: 50885403273948
• UDI-Public: 50885403273948
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 01/31/2022

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/31/2020
• Supplement Date Received by Manufacturer: 01/13/2021
• Initial Report FDA Received Date: 01/21/2021
• Supplement Report FDA Received Date: 02/01/2022
• 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