MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD MAXGUARD EXTENSION SET; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	MX4450
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There were multiple lot numbers reported to be involved.The information for each additional lot number is as follows: medical device lot #: 22049030, medical device expiration date: 04apr2027, device manufacture date: 04apr2022.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported while using bd maxguard extension set the tubing was defective.There was no report of patient impact.The following information was provided by the initial reporter: hospital has notified us that they have experienced a defective iv tubing set.
Event or Problem Description
It was reported while using bd maxguard extension set the tubing was defective.There was no report of patient impact.The following information was provided by the initial reporter: hospital has notified us that they have experienced a defective iv tubing set.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 22-sep-2022.H6: investigation summary: a complaint of a set being defective was received from the customer.Two samples were returned for investigation.Through visual inspection, the customer complaint was confirmed.One sample had separated at the y-port.The separation looked clean and no damage was seen to the tubing.The second sample was not separated, and was able to be primed with no defects observed.A device history record review for model mx4450 lot number 21085161 was performed.The search showed that a total of 4,803 units in 1 lot number were built on 04aug2021.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.A device history record review for model mx4450 lot number 22049030 was performed.The search showed that a total of 14,403 units in 1 lot number were built on 04apr2022.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The manufacturing plant was notified of this defect.The potential root causes were determined to be the tubing not fully being inserted into the bushing, causing a lack of solvent and gap.Another potential root cause is not allowing sufficient time for curing during assembly of the tubing to nac y-site joint.H3 other text : see h10.

• Brand Name: BD MAXGUARD EXTENSION SET
• 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
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15479907
• Report Number: 9616066-2022-01407
• Device Sequence Number: 20519320
• Product Code: FPA
• UDI-Device Identifier: 10885403274671
• UDI-Public: 10885403274671
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K051499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 11/18/2022

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: Health Professional
• Device Expiration Date: 08/04/2026
• Device Catalogue Number: MX4450
• Device Lot Number: 21085161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2022
• Supplement Date Received by Manufacturer: 11/18/2022
• Initial Report FDA Received Date: 09/24/2022
• Supplement Report FDA Received Date: 12/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/02/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown