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

Model Number 10014914

Device Problems Complete Blockage (1094); Restricted Flow rate (1248)

Patient Problem Not Applicable (3189)

Event Date 09/15/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).

Event Description

It was reported that as syr psd microbore tubing would not flush.The following information was provided by the initial reporter: event 1 originated from bag 6: customer sent one open-package 10014914, lot number: 20065193".The customer included a sticky note stating "tubing would not flush.

Event Description

It was reported that as syr psd microbore tubing would not flush.The following information was provided by the initial reporter: event 1 originated from bag 6: customer sent one open-package 10014914, lot number: 20065193".The customer included a sticky note stating "tubing would not flush.

Manufacturer Narrative

H6: investigation summary : it was reported that the tubing of model #10014914, batch #20065193 does not allow fluid to flow through the line.An investigation was performed.The set was unable to be primed and analyzed for defects.Visual inspection under magnification of the engagement between the tubing and female luer observed an occlusion.The root cause was solvent trapped between the edge of the tubing and the female luer component bonding pocket.A device history record review for model 10014914 lot number 20065193 was performed.The search showed that a total of 12,003 units in 1 lot number was built on 03jun2020.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.

• 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: 10646165
• MDR Text Key: 219166655
• Report Number: 9616066-2020-20031
• 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: 11/05/2020

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: 06/02/2023
• Device Model Number: 10014914
• Device Catalogue Number: 10014914
• Device Lot Number: 20065193
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2020
• Initial Date Manufacturer Received: 09/15/2020
• Initial Date FDA Received: 10/07/2020
• Supplement Dates Manufacturer Received: 11/05/2020
• Supplement Dates FDA Received: 11/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other