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 09/09/2021

Event Type  malfunction  

Manufacturer Narrative

There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 20115323.Medical device expiration date: 2023-11-12.Device manufacture date: 2020-11-12.Medical device lot #: an invalid lot # of 20095129 was provided by the initial reporter.Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: two 20039e7d samples were received for investigation; one from lot 20095129 was in open packaging and one without packaging.The customer feedback indicates that the complaint sample was from lot 20115323.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 20095129 and 20115323 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 product in the past 12 months.Investigation conclusion: two 20039e7d samples were received for investigation; one from lot 20095129 was in open packaging and one without packaging.The customer feedback indicates that the complaint sample was from lot 20115323.The connecting product in use at the time of the customer's experience was not returned to assist the investigation.

Event Description

It was reported that 5 smallbore 6 inch ext vlv, 7 day were clogged.The following information was provided by the initial reporter: some of smartsite extension sets (single) are not flushing with saline.There is resistance while priming and flushing.

• 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: 12651963
• MDR Text Key: 277133363
• Report Number: 9616066-2021-52246
• 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: 09/22/2021

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
• Device Operator: Other
• Device Catalogue Number: 20039E7D
• Device Lot Number: SEE H10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2021
• Initial Date Manufacturer Received: 09/20/2021
• Initial Date FDA Received: 10/18/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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