MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD GRAVITY SET 10DP CKV 2SMS DEHP FREE; INTRAVASCULAR ADMINISTRATION SET

Model Number 47177E

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

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

Event Date 08/26/2021

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: one sample was submitted for quality investigation.The customer complaint of foreign matter was verified by visual inspection.Evaluation of the drip chamber revealed pieces of foreign matter embedded in body of the drip chamber.A device history record review for model 47177e lot number 21019569 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 22jan2021.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The root cause of the issue seen in this complaint is related a manufacturing issue.A similar issue, seen in previous investigations, have found that this foreign matter embedded in the drip chamber body is a result directly related to the supplier molding process.This incident has been added to our database of reported incidents.

Event Description

It was reported when using the bd gravity set 10dp ckv 2sms dehp free, the device experienced foreign matter in the fluid pathway.The following information was provided by the initial reporter.The customer stated: "there is something in the tube section of the device and the nurse wasn't for sure if it would come loose and go into the tubing that goes to the patient.".

• Brand Name: BD GRAVITY SET 10DP CKV 2SMS 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
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12510044
• MDR Text Key: 272694450
• Report Number: 9616066-2021-52106
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 50885403235434
• UDI-Public: 50885403235434
• 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: 08/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/22/2024
• Device Model Number: 47177E
• Device Catalogue Number: 47177E
• Device Lot Number: 21019569
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/26/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/22/2021
• 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