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

Catalog Number	10800175
Medical Device Problem Codes	Crack (1135); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.Fda notified?: the initial reporter also notified the fda via medwatch # (b)(4).A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that the bd alaris pca administration kit cracked and leaked.The following information was provided by the client: "patient had a pca and the connection port between the pca and the primary ivf cracked and leaked.Per rn report, this was the 2nd patient that she has known this to happen to.".
Event or Problem Description
It was reported that the bd alaris pca administration kit cracked and leaked.The following information was provided by the client: "patient had a pca and the connection port between the pca and the primary ivf cracked and leaked.Per rn report, this was the 2nd patient that she has known this to happen to.".
Additional Manufacturer Narrative
H6: investigation summary: a complaint of a connection port cracking and leaking was received from the customer.No product or photo was returned by the customer.The customer complaint of component damage 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 10800175 because a lot number is unknown.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.

• Brand Name: BD ALARIS PCA ADMINISTRATION KIT
• 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: 13693561
• Report Number: 9616066-2022-00207
• Device Sequence Number: 4930627
• Product Code: FPA
• UDI-Device Identifier: 10885403234408
• UDI-Public: 0110885403234408
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2022

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: Health Professional
• Device Catalogue Number: 10800175
• 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: 02/22/2022
• Supplement Date Received by Manufacturer: 03/09/2022
• Initial Report FDA Received Date: 03/08/2022
• Supplement Report FDA Received Date: 03/29/2022
• 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