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

Model Number	20028E
Medical Device Problem Codes	Break (1069); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.Device manufacture date: unknown.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported while using bd alaris smartsite extension set there was damage to the clamp and leakage occurred.There was no report of patient (pt) impact.The following information was provided by the initial reporter: primary rn reporting blood coming from pt's picc line.Upon evaluation from primary rn tpn filter tubing had broken.Picc line was immediately clamped.Leur lock was still attached to the pt's picc line from the filter tubing.The tubing broke right after the leur lock.Pt was bleeding from the picc line since the clamp was not closed.
Additional Manufacturer Narrative
H6: investigation summary no product or photo was returned by the customer.The customer complaint of separation could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed on model 20028e 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.
Event or Problem Description
It was reported while using bd alaris smartsite extension set there was damage to the clamp and leakage occurred.There was no report of patient impact.The following information was provided by the initial reporter: primary rn reporting blood coming from pt's picc line.Upon evaluation from primary rn tpn filter tubing had broken.Picc line was immediately clamped.Leur lock was still attached to the pt's picc line from the filter tubing.The tubing broke right after the leur lock.Pt was bleeding from the picc line since the clamp was not closed.

• 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: 16261496
• Report Number: 9616066-2023-00110
• Device Sequence Number: 4881226
• Product Code: FPA
• UDI-Device Identifier: 07613203012393
• UDI-Public: (01)07613203012393
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 02/07/2023

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 Model Number: 20028E
• Device Catalogue Number: 20028E
• 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: 01/10/2023
• Supplement Date Received by Manufacturer: 02/07/2023
• Initial Report FDA Received Date: 01/28/2023
• Supplement Report FDA Received Date: 02/21/2023
• 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