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

Catalog Number	42081E
Medical Device Problem Codes	Break (1069); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2023
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.Address information was not able to be obtained, therefore, nj was used as a place holder.Medical device lot #: the customer reported lot #1022109380, but this was not found to be associated with the reported material number.
Event or Problem Description
It was reported that the bd alaris smartsite gravity blood set tubing was damaged and leaked.The following information was provided by the initial reporter: possible cracked tubing.Blood leaking from tubing insertion site going into ggt chamber.
Additional Manufacturer Narrative
H6: investigation summary no product or photo was returned by the customer.The customer complaint of tubing defective/damaged - leakage could not be verified due to the product not being returned for failure investigation.A device history record review for model 42081e lot number 22109380 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.H3 other text : see h10.
Event or Problem Description
It was reported that the bd alaris smartsite gravity blood set tubing was damaged and leaked.The following information was provided by the initial reporter: possible cracked tubing.Blood leaking from tubing insertion site going into ggt chamber.

• Brand Name: BD ALARIS SMARTSITE GRAVITY BLOOD 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 ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 16959331
• Report Number: 9616066-2023-00952
• Device Sequence Number: 14825649
• Product Code: FPA
• UDI-Device Identifier: 07613203020855
• UDI-Public: (01)07613203020855
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K882302
• 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): 05/31/2023

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: 42081E
• Device Lot Number: 1022109380
• 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: 04/26/2023
• Supplement Date Received by Manufacturer: 05/31/2023
• Initial Report FDA Received Date: 05/18/2023
• Supplement Report FDA Received Date: 06/13/2023
• 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