MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. GRAVITY SET 60DP 3SS DEHP FREE; INTRAVASCULAR ADMINISTRATION SET

Model Number 42434E

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

Event Date 12/03/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.Device manufacture date: unknown.(b)(4).Investigation summary: a complaint of foreign matter found in the set was received from the customer.One sample was returned for investigation.A device history record review could not be performed on model 42434e because an invalid lot number was provided by the customer.Investigation conclusion: through visual inspection of the returned sample the customer complaint was verified.Brown matter could be found inside the top of the drip chamber.Previous investigations have found this material on the drip chamber spike.Root cause description: the root cause has been determined to be a result of the supplier process in which the drip chamber component has come into contact with grease used in the molding machinery.Rationale: 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

It was reported that foreign matter was found in the gravity set 60dp 3ss dehp free tubing.The following information was provided by the initial reporter: "there appears to be debris in the tubing, was noticed prior to using on patient.No patient harm".

• Brand Name: GRAVITY SET 60DP 3SS DEHP FREE
• 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: 11103397
• MDR Text Key: 246125896
• Report Number: 9616066-2020-20706
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K820278
• 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: 12/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 42434E
• Device Catalogue Number: 42434E
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/03/2020
• Was Device Evaluated by Manufacturer?: Yes
• 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