MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. SEC SET NO PORTS W/HANGER DEHP FREE; INTRAVASCULAR ADMINISTRATION SET

Catalog Number 11448964

Device Problem Leak/Splash (1354)

Patient Problem No Patient Involvement (2645)

Event Date 12/02/2020

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: na.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 set no ports w/hanger dehp free experienced component separation.The following information was provided by the initial reporter: material no: 11448964.Batch no: 20083415.Nurse grabbed a secondary set and noticed the tubing was apart.She brought it to me and i called iv team educator.Bedside rn was preparing for a secondary infusion.When tubing was open tubing was not connected to bottom of drip chamber.Appears to be no bonding between pieces.

Event Description

It was reported that the sec set no ports w/hanger dehp free experienced component separation.The following information was provided by the initial reporter: material no: 11448964, batch no: 20083415.Nurse grabbed a secondary set and noticed the tubing was apart.She brought it to me and i called iv team educator.Bedside rn was preparing for a secondary infusion.When tubing was open tubing was not connected to bottom of drip chamber.Appears to be no bonding between pieces.

Manufacturer Narrative

H6: investigation summary.Customer reported tubing disconnected and returned the affected sample.The sample was clearly separated at the outlet of the drip chamber and the complaint is verified.Visual inspection under the microscope determined the root cause to be insufficient solvent.Dimensional analysis found the tubing to be within tolerance.No other failure modes were observed.A device history record review for model 11448964 lot number 20083416 was performed.H3 other text : see h.10.

• Brand Name: SEC SET NO PORTS W/HANGER 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
• MDR Report Key: 11103176
• MDR Text Key: 227021669
• Report Number: 9616066-2020-20703
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403234743
• UDI-Public: 10885403234743
• 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: 01/05/2021

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: Health Professional
• Device Catalogue Number: 11448964
• Device Lot Number: 20083415
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2020
• Date Manufacturer Received: 01/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1