MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C. GEM V/NV 20D 1CV 2SS DEHP FREE; INTRAVASCULAR ADMINISTRATION SET

Catalog Number 2420-0007

Device Problem Contamination (1120)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/08/2020

Event Type  malfunction  

Manufacturer Narrative

Device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that the gem v/nv 20d 1cv 2ss dehp free experienced cracks/holes to tubing or any other component leaking.The following information was provided by the initial reporter: infusion can¿t pass smoothly when connect with set sample destroyed due to contaminated with blood.Only photo available.During use quantity : 1.

Event Description

It was reported that the gem v/nv 20d 1cv 2ss dehp free experienced cracks/holes to tubing or any other component leaking.The following information was provided by the initial reporter: infusion can¿t pass smoothly when connect with set sample destroyed due to contaminated with blood.Only photo available.During use quantity : 1.

Manufacturer Narrative

One 2420-0007 sample was received for investigation with residual fluid within the line and no packaging; the sample was received connected to a 100ml freeflex iv bag.A visual inspection of the sample did not identify any signs of damage or manufacturing defect which could have contributed to the customer's experience.The sample was subjected to pressure testing; no leakage was observed from any joint throughout testing.Furthermore a close inspection of each of the joints, did not identify any obvious damage or separation which may have contributed to the customer's experience the details of this feedback were forwarded to the manufacturing site for investigation.In this instance a lot number was not available and therefore it is not possible to perform a review of the production documentation for this particular product.It was not possible to confirm the root cause of the reported issue in this instance.Testing of the returned sample did not identify any product defects or quality deviations that could have contributed to the customer¿s experience.In this instance no manufacturing defects were observed to the returned sample and therefore it was not possible to link this feedback to a specific failure mode.

• Brand Name: GEM V/NV 20D 1CV 2SS DEHP FREE
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): SISTEMAS MEDICOS ALARIS, S.A. DE C.; blvd. insurgentes 20351; tijuana, null 22244 ; MX 22244
• MDR Report Key: 10109669
• MDR Text Key: 194117849
• Report Number: 9616066-2020-01651
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 07613203021012
• UDI-Public: 07613203021012
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 05/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 2420-0007
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 0
• Treatment: (B)(6) 2020