MAUDE Adverse Event Report: ANES CIRCUIT, ADULT, 60 IN CORR, 3L BAG; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)

Model Number ANES CIRCUIT, ADULT, 60 IN CORR, 3L BAG

Device Problem Disconnection (1171)

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

Event Date 08/04/2021

Event Type  malfunction  

Event Description

The customer reported that the elbow and hme are separating a little too easily on the gak10xxx-anes circuit, adult, 60 in corr, 3l bag.The issue was detected while connected to a patient, there was no harm or delay of treatment.

Manufacturer Narrative

Any additional information received from the customer will be included in a follow-up report.The suspect device was returned and evaluation is anticipated but not yet begun.Once a final investigation is complete, a follow-up report will be submitted.

Manufacturer Narrative

The device history record of the (fg) p/n gak1oxxx with lot number 0004183908 and the sub-assembly p/n r5040elma with lot number 1312024 was reviewed in order to detect any issue related with the defect reported by the customer during its manufacturing and no issues were found.Some pictures were provided for the investigation, they were observed and no issues were found on it.In addition, two samples were provided for evaluation; elbow r5040elma and filter r557055200.A visual and dimensional inspection were performed on samples and no issues were found on them, samples met with the specifications.However, elbow (r5040elma) and filter (r557055200) are in the minimum specification, it could cause a poor squeezy between them and provoke that elbow separate too easily.Any additional information received from the customer will be included in a follow-up report.

• Brand Name: ANES CIRCUIT, ADULT, 60 IN CORR, 3L BAG
• Type of Device: CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
• MDR Report Key: 12424508
• MDR Text Key: 280592072
• Report Number: 8030673-2021-00193
• Device Sequence Number: 1
• Product Code: CAI
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 08/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ANES CIRCUIT, ADULT, 60 IN CORR, 3L BAG
• Device Catalogue Number: GAK1OXXX
• Device Lot Number: 0004183908
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2021
• Date Manufacturer Received: 09/02/2021
• 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