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

Catalog Number	MX4436
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each additional lot number is as follows: medical device lot #: 22085393; medical device expiration date: 11-aug-2025; device manufacture date: 05-aug-2022; medical device lot #: 22085615; medical device expiration date: 18-aug-2025; device manufacture date: 11-aug-2022.
Event or Problem Description
It was reported that 3 of the bd maxguard drop administration set would not prime.The following information was provided by the initial reporter: item will not prime.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 09-jan-2023.H6: investigation summary; a complaint of 5 sets unable to be primed was received from the customer.6 samples were returned for investigation.3 samples would not prime.Fluid could not pass the drip chamber.The other 3 samples were able to be primed, but a syringe was connected to a needless valve to help the fluid flow.A device history record review for model mx4436 lot number 22085393 was performed.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 mx4436 lot number 22085615 was performed.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.A walkthrough of the manufacturing process was performed to identify the root cause.It was determined that the cause was an excess amount of solvent added during assembly.A quality alert was issued to all involved personnel to inform of this failure and reinforce the operations described in the procedure to avoid excess solvent in the product.H3 other text : see h10.
Event or Problem Description
It was reported that 3 of the bd maxguard drop administration set would not prime.The following information was provided by the initial reporter: item will not prime.

• Brand Name: BD MAXGUARD DROP ADMINISTRATION 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: 16075048
• Report Number: 9616066-2022-02093
• Device Sequence Number: 6262579
• Product Code: FPA
• UDI-Device Identifier: 10885403237478
• UDI-Public: 10885403237478
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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): 02/24/2023

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 Catalogue Number: MX4436
• Device Lot Number: SEE H.10
• 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: 12/01/2022
• Supplement Date Received by Manufacturer: 02/24/2023
• Initial Report FDA Received Date: 12/29/2022
• Supplement Report FDA Received Date: 03/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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