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 Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd alaris¿ pca administration set experienced device damage while considered operable, and leakage.The following information was provided by the initial reporter: bd pca administration set was found by the bedside rn to be cracked at the port that was connected to a patient's tpn and intralipid line.There were no events that led up to the crack.No harm was reported to the patient.The line was replaced with no further problems.
Additional Manufacturer Narrative
Device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Additional Manufacturer Narrative
Investigation summary: one sample was submitted for quality investigation.The customer complaint of component damage - leak was verified by visual inspection.Investigation of the sample revealed a large crack at the female luer adapter connector.A device history record review could not be performed because the lot number is unknown.The root cause for the crack seen in the luer adapter could not be fully determined based on the description of event by the customer.The probable root cause for the damage is that a large amount of force was used to connect luer adapter to its corresponding connector causing it to crack along the length of the adapter.Additionally, if luer connector was cleaned with an antiseptic prior to use, the material that luer is made from can weaken the strength of the luer body, making it easier to crack.H3 other text : see h10.
Event or Problem Description
It was reported that the bd alaris¿ pca administration set experienced device damage while considered operable, and leakage.The following information was provided by the initial reporter: bd pca administration set was found by the bedside rn to be cracked at the port that was connected to a patient's tpn and intralipid line.There were no events that led up to the crack.No harm was reported to the patient.The line was replaced with no further problems.

• 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: 15936694
• Report Number: 9616066-2022-01888
• Device Sequence Number: 15051590
• Product Code: FPA
• UDI-Device Identifier: 50885403273948
• UDI-Public: 50885403273948
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: 12/01/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2022
• Supplement Date Received by Manufacturer: 12/09/2022
• Initial Report FDA Received Date: 12/07/2022
• Supplement Report FDA Received Date: 12/26/2022
• 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