MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. AS SYR PSD MICROBORE; INTRAVASCULAR ADMINISTRATION SET

Model Number 10014914

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/19/2020

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 iv fluid leaked from the as syr psd microbore during use.The following information was provided by the initial reporter: "iv fluid found on floor.Leak observed at base of clave and top of syringe tubing during infusion.".

Manufacturer Narrative

H6: investigation summary: no product or photo was returned by the customer.The customer complaint of leak at base of calve and top of syringe could not be verified due to the product not being returned for failure investigation.The root cause of this failure could not be identified without a failure investigation.A device history record review for model 10014914 lot number 20015796 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 09jan2020.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.H3 other text : see h.10.

Event Description

It was reported that iv fluid leaked from the as syr psd microbore during use.The following information was provided by the initial reporter: "iv fluid found on floor.Leak observed at base of clave and top of syringe tubing during infusion.".

• Brand Name: AS SYR PSD MICROBORE
• 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: 11084049
• MDR Text Key: 250324828
• Report Number: 9616066-2020-20656
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 50885403233904
• UDI-Public: 50885403233904
• Combination Product (y/n): N
• PMA/PMN Number: K811885
• 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: 01/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/09/2023
• Device Model Number: 10014914
• Device Catalogue Number: 10014914
• Device Lot Number: 20015796
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/30/2020
• Initial Date FDA Received: 12/28/2020
• Supplement Dates Manufacturer Received: 01/15/2021
• Supplement Dates FDA Received: 01/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1