MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX ANESTHESIA CIRCUIT; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)

Lot Number 4206606

Device Problem Fluid/Blood Leak (1250)

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

Event Date 02/01/2022

Event Type  malfunction  

Manufacturer Narrative

One device was received for evaluation in relation to the reported event.Evaluation of the device is currently in progress.Once the evaluation is complete, a follow-up report with evaluation results will be submitted.

Event Description

It was reported that during the pre-use check, leakage of air from the product was observed.A tear or scratch in the corrugated tube was found.There was no patient injury reported.

Manufacturer Narrative

Device evaluation: the device was returned for investigation.A visual inspection and functional test were performed.Unit was returned for evaluation of the failure and pictures by the customer were provided.Unit returned was received inside of a plastic bag which is not the original package.Visual inspection: the sample was visually inspected: results: sample present a tier damage due embedded resin in the circuit functional test: sample was submitted to leak test inspection per specification qp 2025 rev.104 disposable anesthesia breathing circuit (dabc) / section 1.8 leak test.Leak test results: leak test inspection was performed on the returned device using equipment manometer id# 8.0324 (calibration due date 07/2022).Results: the device presented leakage.Conclusions: based on the visual inspection, the reported nonconformance is confirmed.Sample present leakage.Two process ncr?s (b)(4) / (b)(4) were open it on september 28, 2021, and october 18, 2021, due embedded resin: the root cause identified on ncr (b)(4) / (b)(4) were: 1.Design of nozzle bottom (spare part) generate that resin does not flow continuously, which cause resin accumulation, and this is adhere to the tube.2.Lack of training in the new personal on the process line.The cause of the reported problem was traced to teh manufacturing process.The lot 4206606 was manufactured with (b)(4) units, lot met the requirements to release the lot with no deviations identified during their manufactured.

• Brand Name: PORTEX ANESTHESIA CIRCUIT
• Type of Device: CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer (Section G): NULL; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; 7-15-26 fukushima,; minneapolis, MN 55442
• MDR Report Key: 13859946
• MDR Text Key: 287673598
• Report Number: 3012307300-2022-05038
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 4206606
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/14/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1