MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD MAXPLUS¿ NEEDLE-FREE CONNECTOR; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	MP9232-C
Medical Device Problem Codes	Break (1069); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd maxplus¿ needle-free connector was cracked and leaking.The following information was provided by the initial reporter: while changing out set and after all infusions were restarted for about 5 minutes, patient c/o feeling leakage of fluid from iv site.Rn assessed and noticed the max-plus connector was cracked in several pieces.Rn removed the connector and as she was getting ready to change out, she noticed a backflow of blood coming out of the y-site back check valve on the mainline and a pool of blood on linen.Iv line immediately dc'd and switched out.
Additional Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device expiration date: unknown.Device manufacture date: unknown.
Event or Problem Description
It was reported that the bd maxplus¿ needle-free connector was cracked and leaking.The following information was provided by the initial reporter: while changing out set and after all infusions were restarted for about 5 minutes, patient c/o feeling leakage of fluid from iv site.Rn assessed and noticed the max-plus connector was cracked in several pieces.Rn removed the connector and as she was getting ready to change out, she noticed a backflow of blood coming out of the y-site back check valve on the mainline and a pool of blood on linen.Iv line immediately dc'd and switched out.
Additional Manufacturer Narrative
H6: investigation summary no product or photo was returned by the customer.The customer complaints of tubing defective and leakage could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed because the lot number is unknown.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.

• Brand Name: BD MAXPLUS¿ NEEDLE-FREE CONNECTOR
• 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: 15936620
• Report Number: 9616066-2022-01887
• Device Sequence Number: 12276805
• Product Code: FPA
• UDI-Device Identifier: 10885403237072
• UDI-Public: 10885403237072
• 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): 12/20/2022

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: MP9232-C
• Device Lot Number: UNKNOWN
• 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: 11/15/2022
• Supplement Date Received by Manufacturer: 12/20/2022
• Initial Report FDA Received Date: 12/07/2022
• Supplement Report FDA Received Date: 01/06/2023
• 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