MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD MAXGUARD¿ ADMINISTRATION SET WITH NEEDLELESS Y-SITE; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	MX9128
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 22059113.Medical device expiration date: 11-may-2027, device manufacture date: 06-may-2022.Medical device lot #: 22059057, medical device expiration date: 06-may-2027, device manufacture date: 03-may-2022.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that 1 bd maxguard¿ administration set with needleless y-site each from lots 22059113 and 22059057 were blocked and wouldn't allow fluid past the first hub during use.The following information was provided by the initial reporter: "i am receiving numerous complaints about this iv tubing from end users mainly in our pre-op department.This time it is a different lot #.Staff is reporting that the tubing will not allow fluids to move pass the first hub.No kinks were found.Requiring them to open a new set and exchange out.".
Additional Manufacturer Narrative
H6: investigation summary no product or photo was returned by the customer.It was reported that "tubing will not allow fluids to move pass the first hub.No kinks were found".The customer complaint could not be verified due to the product not being returned for failure investigation.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.A device history record review for model mx9128 lot number 22059113 was performed.The search showed that a total of 8,253 units in 1 lot number was built on 12may2022.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 mx9128 lot number 22059057 was performed.The search showed that a total of 14,403 units in 1 lot number was built on 11may2022.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 h10.
Event or Problem Description
It was reported that 1 bd maxguard¿ administration set with needleless y-site each from lots 22059113 and 22059057 were blocked and wouldn't allow fluid past the first hub during use.The following information was provided by the initial reporter: "i am receiving numerous complaints about this iv tubing from end users mainly in our pre-op department.This time it is a different lot #.Staff is reporting that the tubing will not allow fluids to move pass the first hub.No kinks were found.Requiring them to open a new set and exchange out.".

• Brand Name: BD MAXGUARD¿ ADMINISTRATION SET WITH NEEDLELESS Y-SITE
• 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: 15433493
• Report Number: 9616066-2022-01348
• Device Sequence Number: 6071116
• Product Code: FPA
• UDI-Device Identifier: 10885403237621
• UDI-Public: 10885403237621
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 10/17/2022

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: Other
• Device Catalogue Number: MX9128
• Device Lot Number: SEE H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2022
• Supplement Date Received by Manufacturer: 10/17/2022
• Initial Report FDA Received Date: 09/15/2022
• Supplement Report FDA Received Date: 10/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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