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

Model Number	42290E
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd alaris smartsite gravity set experienced foreign matter, contaminated.The following information was provided by the initial reporter: a large mobile foreign body (appears to be a piece of metal) was discovered in a iv giving set prior to patient use but after it had been run through.Line has fluid in it but has not been used on a patient.
Additional Manufacturer Narrative
H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.D.4 device expiration date: unknown.H.4.Device manufacture date: unknown.
Event or Problem Description
It was reported that the bd alaris smartsite gravity set experienced foreign matter, contaminated.The following information was provided by the initial reporter: a large mobile foreign body (appears to be a piece of metal) was discovered in a iv giving set prior to patient use but after it had been run through.Line has fluid in it but has not been used on a patient.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 22-may-2023.H6: investigation summary one 42290e sample from lot 22079379 was received in opened packaging for investigation; residual fluid was detected in the drip chamber of the device.The feedback provided by the customer suggests a large piece of metal was detected in the tubing.A visual inspection of the returned sample confirmed the customer's experience, as a 1cm piece of metal was detected in the set between the back check valve (bcv) and smartsite y-port connector.The details of this feedback were forwarded to the manufacturing site for investigation.They confirmed that the metal was likely to be a piece of a tubing expander that had inadvertently broken off during the assembly process and was not identified during subsequent assembly steps due to human error.A review of the production records for lot 22079379 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.The expander tip although made of metal, due to its design can be very brittle and easily broken off.As a result of this feedback, the manufacturing site have now both redesigned the expander tip and are using a different alloy of stainless steel which is more malleable to prevent future breakage.

• Brand Name: BD ALARIS SMARTSITE GRAVITY 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 ; 8448235433
• MDR Report Key: 16708712
• Report Number: 9616066-2023-00652
• Device Sequence Number: 12281996
• Product Code: FPA
• UDI-Device Identifier: 37613203010949
• UDI-Public: (01)37613203010949
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K820278
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2023

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: 42290E
• Device Catalogue Number: 42290E
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2023
• Supplement Date Received by Manufacturer: 08/17/2023
• Initial Report FDA Received Date: 04/10/2023
• Supplement Report FDA Received Date: 08/30/2023
• 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