MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. SMALLBORE 6 INCH EXT VLV, 7 DAY; INTRAVASCULAR ADMINISTRATION SET

Catalog Number 20039E7D

Device Problems Complete Blockage (1094); Restricted Flow rate (1248)

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

Event Date 09/24/2021

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: seven 20039e7d samples were received in open packaging for investigation; two from lot 20125582 and five from lot 21055717.The connecting product in use at the time of the customer's experience was not returned to assist the investigation.A visual inspection of the returned samples did not identify any product defects or manufacturing issues which could have caused or contributed to the customer's experience.Functional testing was performed by connecting a retained 50ml bd plastipak syringe from stock to each of the returned samples; in each instance no flow restrictions or occlusions were identified.The details of this feedback were forwarded to the manufacturing site for investigation.A review of the production records for lot 20125582 and 21055717 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.A definitive root cause for the customer's experience could not be determined as no occlusion or flow restriction was observed during testing of the returned smartsite.Following a small number of similar reports, bd has conducted an in-depth investigation to identify any potential contributing factors for occlusion of this nature.The investigation has determined that a potential contributor could be the result of an insufficient amount of fluorosilicone having been injected into the piston of the smartsite during the assembly process; fluorosilicone is used as a lubricant within the smartsite to ensure the consistent opening of the piston when the smartsite is activated, and an insufficient amount may cause a temporary occlusion.Due to previous similar reports of this nature bd is currently recommending when encountering needle-free connector flow issues the following: depress the syringe plunger while the syringe is still attached to the needle free connector.If unable to depress the plunger, pull back on the syringe plunger and depress the syringe plunger again.Repeating this step may assist in opening the needle-free connector valve.Please note, in order to minimize reports for occlusions of this nature, the manufacturing site has repaired the assembly machine to ensure that an adequate amount of fluorosilicone is injected into each smartsite.A review of the customer feedback database indicates that this is a rare occurrence with a small number of similar reports against the 20039e7d set in the past 12 months.

Event Description

It was reported that smallbore 6 inch ext vlv, 7 day was clogged.The following information was provided by the initial reporter: "during set up for iv insertion, extension sets have attempted to be primed with normal saline.Unable to prime sets.".

• Brand Name: SMALLBORE 6 INCH EXT VLV, 7 DAY
• 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
• MDR Report Key: 12694376
• MDR Text Key: 278361944
• Report Number: 9616066-2021-52306
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial
• Report Date: 09/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 20039E7D
• Device Lot Number: SEE H.10.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2021
• Date Manufacturer Received: 09/27/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/08/2021
• 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