MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. MICROBORE BI-FUSE EXTENSION SET, 2 IV CO; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	MZ9265
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/11/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported that the microbore bi-fuse extension set, 2 iv co experienced flow issues.The following information was provided by the initial reporter: material #: mz9265 batch/lot # 20066692.Maxzero bi-fuse was not able to be flushed through either port.No patient involvement.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 2021-01-12.H6: investigation summary: 1 sample was returned by the customer.It was reported that the nurse was unable to flush either port.The ports on the set were each connected to a 10 ml syringe and attempted to be flushed with at least 10 ml of a blue dye/water mixture.The ports were unable to be flushed.The tubing was cut above the luer to see if the occlusion may be in the luer.After this was done, the ports were able to be flushed.Upon further examination of the luer, there appeared to be an occlusion just above the luer, causing fluid to be unable to flow.The complaint was able to be verified.The complaint was forwarded to the manufacturer for further investigation.The failure investigation report dir 10000380153 ver.00 identified the potential root cause as that it is very possible that the assigned operator (in the reported lot) has added double solvent to the junction tubing/male luer and has not properly used the fixture pe-2129 in the operations flow of the model mz9265.A quality alert was created and communicated to production personnel to reinforce the proper use of the fixture pe-2129.A device history record review for model mz9265 lot number 20066692 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 25jun2020.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.
Event or Problem Description
It was reported that the microbore bi-fuse extension set, 2 iv co experienced flow issues.The following information was provided by the initial reporter: material #: mz9265, batch/lot # 20066692.Maxzero bi-fuse was not able to be flushed through either port.No patient involvement.

• Brand Name: MICROBORE BI-FUSE EXTENSION SET, 2 IV CO
• Common Device Name: 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: 11163574
• Report Number: 9616066-2021-50037
• Device Sequence Number: 17017704
• Product Code: FPA
• UDI-Device Identifier: 10885403240775
• UDI-Public: 10885403240775
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K140831
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2021

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
• Operator of Device: Other
• Device Expiration Date: 06/20/2023
• Device Catalogue Number: MZ9265
• Device Lot Number: 20066692
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2021
• Initial Date Received by Manufacturer: 12/16/2020
• Supplement Date Received by Manufacturer: 01/29/2021
• Initial Report FDA Received Date: 01/13/2021
• Supplement Report FDA Received Date: 02/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1