MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS S.A. DE C.V. BD SEC SET 20DP W/HANGER LL DEHP FREE; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 10016073

Device Problem Activation, Positioning or Separation Problem (2906)

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

Event Date 10/23/2023

Event Type  malfunction  

Event Description

It was reported that bd sec set 20dp w/hanger ll dehp free inner ring of spike broke.The following information was provided by the initial reporter: we had an incident involving a set with the inner ring of the spike port breaking off from an iv med bag.(b)(6) 2024 what is the date of the event.(b)(6).Describe any patient harm, injury, complication or negative outcome that occurred because of the event.The inner ring of the spike port broke off form the iv med bag.There was no patient harm, injury, complications or negative outcome.

Manufacturer Narrative

It was reported by customer that they had an incident involving a set with the inner ring of the spike port breaking off from an iv med bag.No product or photo was returned by the customer.The customer complaint of separation other component - leak could not be verified due to the product not being returned for failure investigation.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.A device history record review could not be performed because the lot number is unknown.This incident has been added to our database of reported incidents.

• Brand Name: BD SEC SET 20DP W/HANGER LL DEHP FREE
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• 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: 18861119
• MDR Text Key: 337778170
• Report Number: 9616066-2024-00379
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 50885403230118
• UDI-Public: (01)50885403230118
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K790582
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 10016073
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 02/16/2024
• 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