MAUDE Adverse Event Report: ST PAUL PORTEX DISPOSABLE BREATHING CIRCUITS; CIRCUIT, BREATHING

Catalog Number CA12B0/000/000JP

Device Problem Gas/Air Leak (2946)

Patient Problem No Patient Involvement (2645)

Event Date 04/01/2020

Event Type  malfunction  

Manufacturer Narrative

Other, other text: one portex disposable breathing circuit was returned for analysis.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.The manufacturing process was also review; no discrepancies found.Leak testing was then performed on the returned sample with no observed leakage.Based on the evidence there is no root cause as the complaint was not confirmed.

Event Description

Information was received indicating that air was leaking from a smiths medical portex disposable breathing circuit during pre-use check.There were no reported adverse effects.

• Brand Name: PORTEX DISPOSABLE BREATHING CIRCUITS
• Type of Device: CIRCUIT, BREATHING
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: david halverson ; 6000 nathan lane north; aichi pref.; minneapolis, MN 55442
• MDR Report Key: 10075445
• MDR Text Key: 191580315
• Report Number: 3012307300-2020-04629
• 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: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: CA12B0/000/000JP
• Device Lot Number: 200319
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/23/2020
• Initial Date FDA Received: 05/20/2020
• 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: Unknown
• Patient Sequence Number: 1