MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. SEC W/SS DC 20DP & HANGER TEX; INTRAVASCULAR ADMINISTRATION SET

Catalog Number 10013364T

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/30/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation summary: no product or photo was returned by the customer.The customer complaint of separation below drip chamber could not be verified due to the product not being returned for failure investigation.A device history record review for model 10013364t lot number 20085433 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 26aug2020.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Investigation conclusion: this incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.Root cause description: the root cause of this failure could not be identified without a failure investigation.Rationale: since no samples displaying the reported condition were received corrective actions are not necessary.

Event Description

It was reported that sec w/ss dc 20dp & hanger tex broke.The following information was provided by the initial reporter: event 2: incident date: (b)(6) 2020, material #: 10013364t, batch/ lot #: (10)20085433.Not contaminated with chemo and discarded it was reported that on two separate occurrences, the secondary set broke below the non vented drip chamber that connects to the tubing.

• Brand Name: SEC W/SS DC 20DP & HANGER TEX
• 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 22244 ; MX 22244
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana 22244 ; MX 22244
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 11087444
• MDR Text Key: 250332144
• Report Number: 9616066-2020-20664
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403198915
• UDI-Public: 10885403198915
• 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: other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/15/2020

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 Expiration Date: 08/26/2023
• Device Catalogue Number: 10013364T
• Device Lot Number: 20085433
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/30/2020
• Initial Date FDA Received: 12/29/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1