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

Model Number	20051E
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd alaris¿ smartsite¿ extension set tubing was missing.The following information was provided by the initial reporter: "no extension tube, only hub, clamp in the package".
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.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, returned to manufacturer on: 03-aug-2022.Investigation summary : one 20051e sample from lot 21106161 was received in opened packaging for investigation.The feedback provided by the customer indicates only the needle free access site and the slide clamp components were received, with the rest of the extension tubing missing.A visual inspection of the returned sample confirms the customers experience as only the smartsite component, slide clamp and approximately 5cm of tubing were received.The tubing appear to be cut, and at the location of the cut the tubing was discoloured.A closer inspection of the packaging revealed a gap in the seal of the packaging.The details of this feedback were forwarded to the manufacturing site for investigation.Previous investigations into complaints of this nature have identified that this type of damage is consistent with that caused when the tubing is caught in the heat seal of the packaging machine.If the set is not coiled in the packaging nest correctly, the seal around the edge of the packaging can be compromised by the tubing protruding out of the packaging.The tubing would then be caught in the packaging heat seal, causing the damaged appearance of the tubing.This is a manually performed assembly step and is likely to have occurred due to human error.A review of the production records for lot 21106161 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.
Event or Problem Description
It was reported that the bd alaris¿ smartsite¿ extension set tubing was missing.The following information was provided by the initial reporter: "no extension tube, only hub, clamp in the package".

• 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: 15212245
• Report Number: 9616066-2022-01143
• Device Sequence Number: 2199424
• Product Code: FPA
• UDI-Device Identifier: 27613203021696
• UDI-Public: 27613203021696
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/05/2022

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 Expiration Date: 10/21/2024
• Device Model Number: 20051E
• Device Catalogue Number: 20051E
• Device Lot Number: 21106161
• 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: 07/18/2022
• Supplement Date Received by Manufacturer: 09/05/2022
• Initial Report FDA Received Date: 08/11/2022
• Supplement Report FDA Received Date: 09/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/20/2021
• 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