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	Crack (1135); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device expiration date: unknown.Device manufacture date: unknown.
Event or Problem Description
It was reported that the bd alaris¿ pca administration set experienced device damage causing leakage.The following information was provided by the initial reporter: leakage noted since pt linens and clothing found to be wet, inspected lines and found to have dripping and crack noted to pca line where maintence fluid was y'd into pca line.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 06-apr-2023.Investigation summary: a complaint of set leaking during use due to damage was received from the customer.A sample was returned for investigation.Through visual inspection, the customer complaint was confirmed.The female luer was cracked.A device history record review could not be performed on model 30873 because the lot number is invalid.An investigation was performed where the manufacturing process was reviewed.A definitive root cause could not be determined.Potential root causes were found to be combination of different factors, including prolonged use of substances that are aggressive to plastics or over-torque of the component during connection with the female luer or damaged directly of supplier (component built by supplier).
Event or Problem Description
It was reported that the bd alaris¿ pca administration set experienced device damage causing leakage.The following information was provided by the initial reporter: leakage noted since pt linens and clothing found to be wet, inspected lines and found to have dripping and crack noted to pca line where maintenance fluid was y'd into pca line.

• 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 ; 8448235433
• MDR Report Key: 16705183
• Report Number: 9616066-2023-00651
• Device Sequence Number: 14371710
• Product Code: FPA
• UDI-Device Identifier: 50885403273948
• UDI-Public: (01)50885403273948
• Combination Product (Y/N): N
• Initial Reporter State: HI
• 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): 04/18/2023

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: 30873
• Device Catalogue Number: 30873
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2023
• Supplement Date Received by Manufacturer: 04/18/2023
• Initial Report FDA Received Date: 04/08/2023
• Supplement Report FDA Received Date: 05/03/2023
• 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