MAUDE Adverse Event Report: NULL PORTEX ADULT DISPOSABLE ANESTHESIA BREATHING CIRCU; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)

Lot Number 4135597

Device Problem Material Split, Cut or Torn (4008)

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

Event Date 08/01/2021

Event Type  malfunction  

Event Description

It was reported that during the use of the product, the breathing bag got partially torn.No patient injury was reported.

Manufacturer Narrative

As part of the investigation, 20 samples were taken to see there is any condition could cause torn, damage (broken): sharp edges on binder's workstation: the test consisted to evaluate if the condition of the binders of the process can be damage / torn the breathing bags.Packaging test: the test consisted to evaluate in this process if the unit can be damage / torn due stuck.Conclusion: it is concluded that failure reported could not be reproduced in the manufacturing process according to the analysis mentioned above.Root cause: the event description provided it by the customer: during the use of the product, the breathing bag got partially torn.Root cause cannot be associated with the manufacturing process since the failure reported could not be reproduced using the tools from assembly and packaging process.Therefor the partially torn was after the product left shm facilities.Dhr: lot 4135597, was manufactured with 3,600 units; lot met the requirements to release the lot with no deviations identified during their manufactured.

• Brand Name: PORTEX ADULT DISPOSABLE ANESTHESIA BREATHING CIRCU
• Type of Device: CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
• Manufacturer (Section G): NULL
• MDR Report Key: 13430077
• MDR Text Key: 287347297
• Report Number: 3012307300-2022-02396
• Device Sequence Number: 1
• Product Code: CAI
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 4135597
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/26/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/30/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1