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 Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd alaris pca administration kit was separated.The following information was received by the initial reporter with the following: when checking a new pca syringe and tubing the tubing tip snapped off into the pca syringe and was no longer able to be used in the pump.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
Material: 10800175 batch#: 22125034.It was reported by the customer that the tubing tip snapped off into the pca syringe and was no longer able to be used in the pump.Rcc received a complaint via email.When checking a new pca syringe and tubing the tubing tip snapped off into the pca syringe and was no longer able to be used in the pump.
Additional Manufacturer Narrative
It was reported by the customer that the tubing tip snapped off into the pca syringe and was no longer able to be used in the pump.One sample and one photo was received for quality investigation.Visual inspection of the sample indicates that there is a piece of a needleless syringe broken off into a female luer connector of the sample of (b)(6).There was no issue found with the tubing sample of (b)(6), however, the syringe tip was broken off into the female luer connector.Further examination of the damage looks as if there syringe tip connection may have not been inserted straight into the corresponding luer connection causing the tip of the syringe to crack into the female connection.The customer complaint of separation was not confirmed, however, there is component damage of the syringe into the female connector.The investigation was continued at the manufacturing location to determine if the failure was caused to the manufacturing of the product.It was determined by manufacturing that the damage on the sample could not be create during manufacturing.The root cause for the damage could not be determined.A device history record review for model 10800175 lot number 22125034 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.

• 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 20750517
• Report Number: 9616066-2024-01712
• Device Sequence Number: 4499436
• Product Code: FPA
• UDI-Device Identifier: 10885403234408
• UDI-Public: (01)10885403234408(11)221125(17)251202(10)22125034
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K022209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2025

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: 12/02/2025
• Device Catalogue Number: 10800175
• Device Lot Number: 22125034
• 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: 10/24/2024
• Supplement Date Received by Manufacturer: 02/06/2025
• Initial Report FDA Received Date: 11/21/2024
• Supplement Report FDA Received Date: 02/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/25/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown