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

Catalog Number UNKNOWN

Device Problem Improper Flow or Infusion (2954)

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

Event Date 01/26/2024

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that unspecified bd infusion set had flow issues the following information was received by the initial reporter with the following verbatim: it was reported by the customer reported one patient had a picc line that clotted off and required removal and subsequent iv placement second patient: the rn noted drops of iv fluid dripping onto the floor.The tubing was immediately changed out.Rcc received a complaint via email.Email(s) attached.1.Any adverse event or serious injury reported to patient or healthcare professional? a.2 events of bd lot # (10)23150138 large infusion tubing leaking b.One patient had a picc line that clotted off and required removal and subsequent iv placement c.Second patient: the rn noted drops of iv fluid dripping onto the floor.The tubing was immediately changed out.No known harm to the patient 2.Was there a delay of, or change in, the course of treatment due to the event? a.Yes, see above, neonatal picc become clotted and required removal and subsequent iv placement 3.Any sample or photo available for investigation? a.Yes see attached 4.How was the patient outcome? are there any clinical signs, health consequences or impact? a.Patient required a septic workup due to risk of infection 5.How was treatment completed for customer? a.I¿m not sure what this question is asking 6.Patient status? a.Multiple new peripheral ivs have been required.Family decline new picc line after the last one required removal 7.Any picture of this complaint a.See attached re: one of the tubing that was leaking 8.Please explain elaborate issue? a.Filter was noted to be wet ~0600 after tubing was changed the evening prior (approximately 9 hour prior) 9.Date of event? 1/26/24 and 1/29/24 10.Physical available/not available? yes both tubings are available 12.Customer address? 8700 beverly blvd los angeles ca 90048.

Event Description

No additional info.

Manufacturer Narrative

No product or photo was returned by the customer.The customer complaint that there was fluid blockage¿ could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed because a model and lot number was not provided by the customer.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.

• Brand Name: UNSPECIFIED BD INFUSION 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: 18827137
• MDR Text Key: 337776721
• Report Number: 9616066-2024-00342
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/24/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1