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

Catalog Number UNKNOWN

Device Problem Break (1069)

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

Event Date 06/06/2023

Event Type  malfunction  

Manufacturer Narrative

E1: initial reporter email address- (b)(6).H.3.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 separated.The following information was received by the initial reporter with the following verbatim: it was reported by the dchu that the sample received did not match the reported material number.The tubing broke off directly below drip chamber and was leaking.A new complaint needs to be generated based on the sample submitted for (b)(4) the sample submitted for this complaint is an unknown secondary set and it does not match the reported (b)(4).The following is the information needed to generate a new complaint.Please generate a new complaint and let me know what the new complaint number is, as i will be the one responsible in completing the complaint.Customer: (b)(6).Initial reporter: address: (b)(6).Phone: (b)(6).Email: (b)(6).Failure: separation.Material: unknown secondary set.Lot: unknown.Awareness date: november 11, 2023 (date in which it was discovered that the submitted sample did not match the reported material number).

Manufacturer Narrative

It was reported that the secondary tubing set was separated.One sample of an unknown secondary infusion set was received for quality investigation.Examination of the sample submitted shows that the tubing separated from below the drip chamber (photos attached).Further evaluation under magnification shows that there is solvent on the drip chamber outlet and the inner surface of the tubing, however, it appears that the solvent had not been uniformly applied on both surfaces.The customer complaint of separation was verified by evaluation of the sample.A device history record review could not be performed because the lot number is unknown.A root cause for the failure seen in the sample could not be fully determined because the material and lot number are unknown.The probably root cause for the failure is that an insufficient amount of solvent was applied at the union between the drip chamber outlet and tubing.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.

Event Description

No additional information was provided.Material: unknown batch: unknown.It was reported by the dchu that the sample received did not match the reported material number.The tubing broke off directly below drip chamber and was leaking.A new complaint needs to be generated based on the sample submitted for (b)(4).The sample submitted for this complaint is an unknown secondary set and it does not match the reported (b)(4).The following is the information needed to generate a new complaint.Please generate a new complaint and let me know what the new complaint number is, as i will be the one responsible in completing the complaint.Customer: hospital (b)(6) initial reporter: (b)(6).Failure: separation.Material: unknown secondary set.Lot: unknown.Awareness date: november 11, 2023 (date in which it was discovered that the submitted sample did not match the reported material number).

• 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: 18270436
• MDR Text Key: 330352958
• Report Number: 9616066-2023-02326
• 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: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/20/2024

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
• Device Operator: Other
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/11/2023
• Initial Date FDA Received: 12/05/2023
• Supplement Dates Manufacturer Received: 03/20/2024
• Supplement Dates FDA Received: 04/04/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1