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

Lot Number 210325

Device Problem Material Puncture/Hole (1504)

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

Event Type  malfunction  

Manufacturer Narrative

Customer facility phone number: (b)(6).The breathing circuit and the breathing bag were returned.A tear was found on the inside center of the bag.There reported issue was confirmed.The root cause was found to be due to manufacturing.The device history record was reviewed and showed that this device met all manufacturing specification for product released for distribution.No issues were identified that would have impacted this event.

Event Description

Information was received indicating that a smiths medical breathing circuit had a pinhole in the breathing bag.There was no patient injury reported and no reported adverse events.

Manufacturer Narrative

Other, other text: h6: event problem and evaluation codes: updated after device evaluation.H10: device evaluation: the breathing circuit and the breathing bag were returned for investigation.A visual inspection and functional test were performed.Visual inspection results: when observing the surface of the anesthesia bag, it was confirmed that there was a tear inside the center of the bag.Conclusion: the reported event was confirmed.Root cause: the root cause may be due to manufacturing.Review of manufacturing records, relevant to the lot reported, found no discrepancies or anomalies.Actions: the sample was sent to mtij for further investigation.Mtij testing/inspection: one unit was returned for evaluation of the failure.Unit returned was received inside of a plastic bag which is not the original package.The non-conformity as pinhole in the breathing bag is confirmed.Current process review: leak test inspection was performed in the piece returned through the equipment id 8.0618.Specification qp dabb rev.009.Results: piece returned was detectable as rejectable.Conclusion: it is concluded that failure reported could not be reproduced using the tools from assembly and packaging process.Cannot confirm the failure, the most probable root cause is that pinholes occurred after the product left smiths medical facilities.The cause of the reported problem was traced to the user manipulation of the device during usage.No corrective actions were taken since the investigation did not reveal that the defect was caused during the manufacturing process.

• Brand Name: PORTEX BREATHING CIRCUIT
• Type of Device: CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
• Manufacturer (Section G): NULL
• MDR Report Key: 11992895
• MDR Text Key: 256022315
• Report Number: 3012307300-2021-05983
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 210325
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/06/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Race: Asian