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

Catalog Number	30873
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical 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.
Event or Problem Description
It was reported that the bd alaris¿ pca administration set leaked from the connection port during use.The following information was provided by the initial reporter: "reported issue: leaking pca tubing ¿ ivf leaking from connection port of the pca tubing.Changed primary tubing but still leaking.Change pca tubing and leak stopped.".
Event or Problem Description
It was reported that the bd alaris¿ pca administration set leaked from the connection port during use.The following information was provided by the initial reporter: "reported issue: leaking pca tubing ¿ ivf leaking from connection port of the pca tubing.Changed primary tubing but still leaking.Change pca tubing and leak stopped".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 15-nov-2022.H6: investigation summary the customer returned a used mat# 30873 sample with the complaint of leakage.Visual analysis was performed and the device female luer was found to have a hairline crack in it which was then analyzed under microscope.This verified the customer's complaint and the leakage root cause is most likely due to a over tightening of luer with a non bd device.The manufacturer was made aware of this issue.A device history record review could not be performed because a lot number was not provided by the customer.

• 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: 15884191
• Report Number: 9616066-2022-01823
• Device Sequence Number: 5071880
• Product Code: FPA
• UDI-Device Identifier: 10885403273940
• UDI-Public: (01)10885403273940
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 01/13/2023

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 Catalogue Number: 30873
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/02/2022
• Supplement Date Received by Manufacturer: 01/13/2023
• Initial Report FDA Received Date: 11/30/2022
• Supplement Report FDA Received Date: 01/31/2023
• 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