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

Catalog Number 20059E-0006

Device Problem Partial Blockage (1065)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/11/2022

Event Type  malfunction  

Event Description

It was reported that the bd¿ smartsite catheter administration set had flow issues during use.The following information was provided by the client: "as per email from clinician: i always activate my syringes before i start flushing them ¿ with that syringe i had still attached a definitely made sure it wasn t sticking etc several times and in front of another nurse, and could not despite multiple disconnecting and reconnecting ever flush that extension set.I dont know why it suddenly worked, but several of the other extension sets from the same lot i had to reconnect several times before i could flush through it, and that was all with 1 single flush syringe flushing multiple different extension sets, but always required several attempts.Weird.I dont know what to say.".

Manufacturer Narrative

Medical device expiration date: unknown.Device manufacture date: unknown.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the bd¿ smartsite catheter administration set had flow issues during use.The following information was provided by the client: "as per email from clinician: i always activate my syringes before i start flushing them ¿ with that syringe i had still attached a definitely made sure it wasn¿t sticking etc several times and in front of another nurse, and could not despite multiple disconnecting and reconnecting ever flush that extension set.I don¿t know why it suddenly worked, but several of the other extension sets from the same lot i had to reconnect several times before i could flush through it, and that was all with 1 single flush syringe flushing multiple different extension sets, but always required several attempts.Weird.I don¿t know what to say.".

Manufacturer Narrative

The following fields were updated due to additional information: d.4.Medical device lot #: 21076083.D.4.Medical device expiration date: 19-jul-2024.H.4.Device manufacture date: 15-jul-2021.D.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 29-mar-2022.H.6.Investigation: one 20059e-0006 sample was received for investigation; the product was received without packaging, however the customer indicated that the complaint sample was from lot 21076083.The sample was received with residual fluid in line and was connected to a 10ml 0.9% nacl bd posiflush sp syringe.Information provided by the customer indicates that the 20059e-0006 product was occluded as it would not flush through after several attempts of connecting and disconnecting the syringe.The 20059e-0006 product was connected to the returned 10ml bd posiflush sp syringe before flushing through with fluid; the piston of the smartsite opened upon connection to the syringe.In this instance it was not possible to replicate the customer's experience, as the set was successfully flushed through and no occlusions or flow restrictions were observed.A review of the production records for lot 21076083 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.Previous complaints for occlusions and flow restrictions have been related to features on the surface of the male luer of the connecting products.These features include flash or a raised edge to the tip of the male luer which have previously been shown to intermittently lead to restricted flow due to them pinching the blue piston of the smartsite and not allowing it to open.This can sometimes be resolved by disconnecting and reattaching the same luer connection which may reposition the luer against the piston and improve the flow, or alternatively by changing the connecting male luer.H3 other text : see h.10.

• Brand Name: BD¿ SMARTSITE CATHETER ADMINISTRATION SET
• Type of Device: 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: 13970228
• MDR Text Key: 288367984
• Report Number: 9616066-2022-00332
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 37613203011908
• UDI-Public: 0137613203011908
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 20059E-0006
• Device Lot Number: 21076083
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/15/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1