MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BAG ACCESS DEVICE; INTRAVASCULAR ADMINISTRATION SET

Catalog Number 2300E

Device Problem Leak/Splash (1354)

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

Event Date 09/02/2021

Event Type  malfunction  

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.

Event Description

It was reported that the bag access device separated at the interface when attaching the syringe to the port.The following information was provided by the initial reporter: "when attaching a syringe to the port, the device appears to have separated at the interface.Can¿t determine if the white half circle shown is residual glue or plastic stress factors.First indicator was air being drawn into the syringe (incomplete seal), and when removal the syringe to inspect, device ¿snapped¿.There was no product loss, and it was conducted in a grade a environment, so minimal risk to the product itself, but thought to raise to your attention in case of a repeat, or more serious occurrence.I think we had a similar problem a year or two ago, wherein not enough adhesive was used to affix the 2 components together.".

Event Description

It was reported that the bag access device separated at the interface when attaching the syringe to the port.The following information was provided by the initial reporter: "when attaching a syringe to the port, the device appears to have separated at the interface.Can¿t determine if the white half circle shown is residual glue or plastic stress factors.First indicator was air being drawn into the syringe (incomplete seal), and when removal the syringe to inspect, device ¿snapped¿.There was no product loss, and it was conducted in a grade a environment, so minimal risk to the product itself, but thought to raise to your attention in case of a repeat, or more serious occurrence.I think we had a similar problem a year or two ago, wherein not enough adhesive was used to affix the 2 components together.".

Manufacturer Narrative

H.6.Investigation: one 2300e sample was received without packaging for investigation.The customer feedback indicates that the sample was from lot 20105599.Further information provided by the customer indicates that the damage was observed after the 2300e product had been accessed 1-2 times.A visual inspection confirmed the customer's experience as the product was received with the smartsite broken from the spike component, with the tip of the smartsite remaining bonded to the spike component.A closer inspection identified white stress marks at the observed damage.A definitive root cause for the customer's experience could not be determined in this instance.The observed damage is consistent with the component being subjected to an external force; in this instance as the damage was observed after the component had already been accessed its unlikely that a manufacturing defect had contributed to the customer's experience.A review of the production records for lot 20105599 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.

• Brand Name: BAG ACCESS DEVICE
• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12555226
• MDR Text Key: 274057992
• Report Number: 9616066-2021-52141
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 10/12/2023
• Device Catalogue Number: 2300E
• Device Lot Number: 20105599
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/21/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/02/2020
• 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