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 Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported while using bd alaris¿ pca kit asv microbore cv foreign matter was found in the fluid path.The following information was provided by the initial reporter: material #: 10800175.Batch/ lot #: 21065588.It was reported by the customer that there was debris found on the tubing while removing from the packaging.Verbatim: a pca tubing set that was found to have some kind of contamination in the tubing before use.Event date: (b)(6) 2022.Event summary: went to set up a pca on this patient and when the tubing was taken out of the package, debris was found in the tubing.
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported while using bd alaris¿ pca kit asv microbore cv foreign matter was found in the fluid path.The following information was provided by the initial reporter: material #: 10800175.Batch/ lot #: 21065588.It was reported by the customer that there was debris found on the tubing while removing from the packaging.Verbatim: a pca tubing set that was found to have some kind of contamination in the tubing before use.Event date: (b)(6) 2022.Event summary: went to set up a pca on this patient and when the tubing was taken out of the package, debris was found in the tubing.
Event or Problem Description
It was reported while using bd alaris¿ pca kit asv microbore cv foreign matter was found in the fluid path.The following information was provided by the initial reporter: material#: 10800175, batch/ lot#: 21065588.It was reported by the customer that there was debris found on the tubing while removing from the packaging.A pca tubing set that was found to have some kind of contamination in the tubing before use.Event date: 1/10/2022.Event summary: went to set up a pca on this patient and when the tubing was taken out of the package, debris was found in the tubing.
Additional Manufacturer Narrative
H.6.Investigation: one unused sample was received for investigation.Through visual inspection the customer complaint was confirmed.There was a red brown substance found inside the tubing.It was not embedded into the tubing.A device history record review for model: 10800175, lot number: 21065588 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The manufacturing plant was notified of this complaint.It was determined that the root cause for this defect is an error at the supplier of the tubing.A complaint history check was performed and this is the 1st related complaint reported with the defect/condition of foreign matter with lot#: 21065588, regarding item: 10800175.

• 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 ; 8015296192
• MDR Report Key: 13416504
• Report Number: 9616066-2022-00048
• Device Sequence Number: 4825941
• Product Code: FPA
• UDI-Device Identifier: 10885403234408
• UDI-Public: 10885403234408
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 05/05/2022

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 Expiration Date: 06/19/2024
• Device Model Number: 10800175
• Device Catalogue Number: 10800175
• Device Lot Number: 21065588
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2022
• Supplement Date Received by Manufacturer: 05/05/2022
• Initial Report FDA Received Date: 02/01/2022
• Supplement Report FDA Received Date: 05/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/08/2021
• 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