MAUDE Adverse Event Report: Y S R PLASTICS INDUSTRIES LTD ADULT ANESTHESIA BREATHING CIRCUIT, 4M, DISPOSABLE, FOR IVENTTM; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)

Catalog Number M1173406

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/08/2018

Event Type  Injury  

Manufacturer Narrative

At this time, vyaire has not received the suspect device/component for evaluation.If additional information becomes available, it will be submitted in a follow up report.

Event Description

The customer reported that the circuit passed pre-procedural testing.However, while in use on the patient, it failed and the doctors had to manually ventilate the patient.There was no known impact to the patient.

Manufacturer Narrative

Results of investigation the component supplier performed an investigation.In-house produced product passed testing at 100%.Representative samples were received from the customer.One sample was correct and another sample examined failed.It was determined this failure was human error that occurred within the supplier's manufacturing facility.Refresher training for the team was conducted.Refinement has been done to definte control processes with an emphasis on strict testing and double checking prior to packaging.Additionally the supplier opened a capa.Any additional information that becomes available will be updated with a supplemental report.

• Brand Name: ADULT ANESTHESIA BREATHING CIRCUIT, 4M, DISPOSABLE, FOR IVENTTM
• Type of Device: CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
• Manufacturer (Section D): Y S R PLASTICS INDUSTRIES LTD; bar lev industrial zoned.n; misgav 201560; IS
• MDR Report Key: 7456948
• MDR Text Key: 106380288
• Report Number: 2050001-2018-00099
• 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: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 04/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: M1173406
• Device Lot Number: 1145
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2019
• Date Manufacturer Received: 01/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention