MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD EXT SET W/ VLV PORT & LL; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	30207E
Medical Device Problem Code	Failure to Disconnect (2541)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/18/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using bd ext set w/ vlv port & ll the device was difficult to disconnect.There was no report of patient impact.The following information was provided by the initial reporter: received another complaint from our wards re not being able to disconnect the lines from the cannula.
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.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 31-oct-2022.Investigation summary: one 30207e sample was received without packaging for investigation; the lot number of the complaint sample was reported unknown, residual fluid was present in the device.The returned sample was received with the female luer connected to the male luer of an unknown connecting product which had been cut.The feedback provided by the customer indicates difficulty was experienced when attempting to disconnect the smartsite extension set from the connecting lines.As part of the investigation the customer provided a photograph of the complaint sample; analysis of the photograph, in addition to a visual inspection of the returned sample did not identify any defects or manufacturing issues which could have caused or contributed to the customer's experience.Functional testing was performed by connecting the returned sample to various products from bd stock and attempting to flush with fluid; no connection issues or flow issues were detected from the male or female luer, and the components could be easily disconnected in each instance.The details of this feedback were forwarded to the manufacturing site for investigation.In this instance, a definitive root cause could not be identified as testing of the returned sample did not identify any product defects that could have contributed to the customer¿s experience.The lot number was not available and therefore it is not possible to perform a review of the production documentation for this particular product.
Event or Problem Description
It was reported while using bd ext set w/ vlv port & ll the device was difficult to disconnect.There was no report of patient impact.The following information was provided by the initial reporter: received another complaint from our wards re not being able to disconnect the lines from the cannula.

• Brand Name: BD EXT SET W/ VLV PORT & LL
• 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: 15789729
• Report Number: 9616066-2022-01712
• Device Sequence Number: 5616755
• Product Code: FPA
• UDI-Device Identifier: 07613203011495
• UDI-Public: 07613203011495
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2022

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: Health Professional
• Device Catalogue Number: 30207E
• 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: 10/19/2022
• Supplement Date Received by Manufacturer: 11/22/2022
• Initial Report FDA Received Date: 11/14/2022
• Supplement Report FDA Received Date: 12/02/2022
• 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