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

Catalog Number	20059E
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2022
Type of Reportable Event	Malfunction
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.Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each additional lot number is as follows: medical device lot #: 22059392 medical device expiration date: 26-may-2025.Device manufacture date: 25-may-2022.Medical device lot #: 22039174.Medical device expiration date: 11-mar-2025.Device manufacture date: 10-mar-2022.
Event or Problem Description
It was reported that 3 of the bd smartsite¿ extension set are unable to flush.The following information was provided by the initial reporter: we are having significant issues with the smartsite extension sets ref 20059e.About every fourth or fifth one we are unable to flush them.We try to flush with a syringe and sometimes it works, sometimes it doesn't.I have two here that we can give you if you need to look at them.
Event or Problem Description
It was reported that 3 of the bd smartsite¿ extension set are unable to flush.The following information was provided by the initial reporter: we are having significant issues with the smartsite extension sets ref (b)(4).About every fourth or fifth one we are unable to flush them.We try to flush with a syringe and sometimes it works, sometimes it doesn't.I have two here that we can give you if you need to look at them.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 03-jan-2023.H6: investigation summary: 11 used samples for model # 20059e were returned for investigation from customer.It was reported by the customer that the smartsite extension set is unable to flush.The sets were examined for defects and abnormalities.No defects or abnormalities were observed.The sets were attached to a cut off bd syringe to see if a fluid path can be observed while the piston is in the activated position.A fluid path was seen clearly in 3 sets.However shows occlusion in other 8 sets.The sets were then connected to a 10 ml bd syringe filled with water and attempted to be flushed.Three sets were successfully flushed.Eight samples of smartsite extension set were not able to flush even with a slight push to syringe.The customer complaint could be replicated.A device history record review for model 20059e and lot number 22059392 was performed.A device history record review for model 20059e and lot number 22039174 was performed.A device history record review for model 20059e and lot number 22109271 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set of lots.A trend for this occlusion issue has been identified for this product line.A capa (corrective action preventative action) has been initiated, and a team has been assembled in order to investigate the issue.H3 other text : see h10.

• Brand Name: BD 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: 16063716
• Report Number: 9616066-2022-02083
• Device Sequence Number: 17802082
• Product Code: FPA
• UDI-Device Identifier: 07613203012317
• UDI-Public: 07613203012317
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 02/23/2023

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 Catalogue Number: 20059E
• Device Lot Number: SEE H10
• 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: 12/08/2022
• Supplement Date Received by Manufacturer: 02/23/2023
• Initial Report FDA Received Date: 12/28/2022
• Supplement Report FDA Received Date: 03/12/2023
• 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