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

Catalog Number 30883

Device Problems Disconnection (1171); Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/05/2023

Event Type  malfunction  

Event Description

It was reported that bd alaris pca administration set disconnected.The following information was received by the initial reporter with the verbatim: "we have had four separate issues: first a disconnection from a patient, from the pca tubing, second and third, tubing had holes and cracks in it.Fourth a break in the tubing where it connects to the syringe".

Manufacturer Narrative

H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.

Manufacturer Narrative

No product or photo was returned by the customer.The customer complaints of 4 issues: 1.A disconnection from a patient, from the pca tubing; 2.& 3.Tubing had holes and cracks in it; 4.A break in the tubing where it connects to the syringe could not be verified due to the product not being returned for failure investigation.The root cause of this failure could not be identified without a failure investigation.Device history record review for model 30883 lot number 22095083 was performed.The search showed that a total of (b)(4) in 1 lot number was built on 06sep2022.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text : see h.10.

Event Description

No new additional information: material#: 30883, batch number#: 22095083.It was reported by customer that they had four separate issues: first a disconnection from a patient, from the pca tubing, second and third, tubing had holes and cracks in it.Fourth a break in the tubing where it connects to the syringe.Verbatim# "we have had four separate issues: first a disconnection from a patient, from the pca tubing, second and third, tubing had holes and cracks in it.Fourth a break in the tubing where it connects to the syringe".Customer reply: confirm whether the four incidents happened in the same date.If not, please provide the dates separately.Happened on different dates, we work 12 hour shifts so times as estimates only: 12/5/23 @ 2300- pca micro bore tubing found disconnected from syringe, medication leaked onto floor.12/11/23 @ 0900- pca tubing micro bore tubing leaking medication on floor, defects found in pca small bore tubing.12/12/23 @ 2130 -pca tubing micro bore tubing leaking mediation on floor, defects found in pca small bore tubing.12/14/23 @ 0800-luer lock on pca syringe broke off from pca tubing.Describe any patient harm, injury, complication or negative outcome that occurred because of the event.No patient harm was found, other than having to waste a medication.Please confirm any sample or photo available for investigation.If yes, provide the address of the facility for us to ship the return label? i have samples stored away that can be sent back, i will get them today and send them to (b)(4) to get back to you.Did all the four events occurred in the same product.If not, please provide the details.Three events occurred with the pca tubing, another was with a syringe that connects to this same tubing as detailed in original message.

• Brand Name: BD ALARIS PCA ADMINISTRATION SET
• Type of Device: 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: 18480472
• MDR Text Key: 332894009
• Report Number: 9616066-2023-02504
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 50885403273955
• UDI-Public: (01)50885403273955
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K811885
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 30883
• Device Lot Number: 22095083
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/16/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1