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

Model Number	22003E-07
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: unknown.Medical device expiration date: unknown.Device manufacture date: unknown.Medical device lot #: 21119800.Medical device expiration date: 02-nov-2022.Device manufacture date: 02-nov-2021.Medical device lot #: 21119802.Medical device expiration date: 02-nov-2022.Device manufacture date: 02-nov-2021.Medical device lot #: 21119803.Medical device expiration date: 03-nov-2022.Device manufacture date: 03-nov-2021.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 37 bd alaris smartsite extension sets were clogged.The following information was provided by the initial reporter: it was reported that the saline would not flush through the sets.
Event or Problem Description
It was reported that 37 bd alaris smartsite extension sets were clogged.The following information was provided by the initial reporter: it was reported that the saline would not flush through the sets.
Additional Manufacturer Narrative
H6: investigation summary 18 samples (model #22003e-07, lot #21119800), one sample (model #22003e-07, lot #21119803), three samples (model #22003e-07, lot #21119802) and one sample (model #22003e-07, possible lot #21115044) were returned by the customer.It was reported that the saline would not flush through the sets.The sets were examined for defects and abnormalities.No defects or abnormalities were observed.The samples were connected to a cut off syringe tip to check that the fluid path is in an activated position/open when connected to a syringe.The samples were then attempted to be flushed with water using a 10ml bd syringe to confirm an open fluid path.The fluid paths of all of the returned samples were open and were able to be flushed.The failure was unable to be replicated in these samples, and the complaint could not be verified.A root cause was unable to be determined.Due to an increase in incidents of this failure mode, a trend for this occlusion issue has been identified for this product line, a capa (corrective action preventative action) 1998036 has been initiated, and a team has been assembled in order to investigate the issue.A device history record review for model 22003e-07 lot number 21119802 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 03nov2021.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Another possible lot number 21115044 was reported, however no data was found.

• Brand Name: BD ALARIS SMARTSITE 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: 14309409
• Report Number: 9616066-2022-00528
• Device Sequence Number: 5376690
• Product Code: FPA
• UDI-Device Identifier: 50885403242043
• UDI-Public: 50885403242043
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K960280
• 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): 06/29/2022

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 Model Number: 22003E-07
• Device Catalogue Number: 22003E-07
• Device Lot Number: SEE H10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2022
• Supplement Date Received by Manufacturer: 06/29/2022
• Initial Report FDA Received Date: 05/06/2022
• Supplement Report FDA Received Date: 07/30/2022
• 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