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 Information (3190)

Event Date 12/02/2020

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Event Description

It was reported that the sec w/ss dc 20dp & hanger tex experienced component separation and leakage.The following information was provided by the initial reporter: material #: (b)(4), batch/ lot #: 20095609, we report that we are have issues with this chemo tubing.In the past 2 weeks, 3 of these sets have snapped in half and had chemo spilling out.I think it¿s obviously an issue with a lot.

Manufacturer Narrative

H.6.Investigation: one photo of the secondary set was returned from the customer.A separation of the drip chamber from the tubing could clearly be seen.The customer's complaint that the tubing snapped in half was able to be verified.A device history record review for model 10013364t lot number 20095609 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.However, since no physical samples were returned for evaluation, the root cause could not be determined.A complaint history check was performed and this is the 1st related complaint reported with the defect/condition of separation other component - leak with lot #20095609 regarding item #10013364t.

Event Description

It was reported that the sec w/ss dc 20dp & hanger tex experienced component separation and leakage.The following information was provided by the initial reporter: material #: 10013364t batch/ lot #: 20095609 we report that we are have issues with this chemo tubing.In the past 2 weeks, 3 of these sets have snapped in half and had chemo spilling out.I think it¿s obviously an issue with a lot.

• 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
• MDR Report Key: 11122061
• MDR Text Key: 226653661
• Report Number: 9616066-2021-00003
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403198915
• UDI-Public: 10885403198915
• Combination Product (y/n): N
• PMA/PMN Number: K790582
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 01/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/10/2023
• Device Catalogue Number: 10013364T
• Device Lot Number: 20095609
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1