MAUDE Adverse Event Report: NULL PORTEX GENERAL ANESTHESIA BAGS; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Catalog Number 670003

Device Problem Tear, Rip or Hole in Device Packaging (2385)

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

Event Type  malfunction  

Event Description

It was reported a 3 liter non-latex breathing bag was found torn at the neck directly underneath the white securement tape and two large face mask on both mask, plastic port connections (used to connect either a resuscitation bag or anesthesia circuit) is dented and the shape is a letter d.No patient injury reported.

Manufacturer Narrative

This mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacturing.The product was returned and visual testing was performed no damages were detected on the samples.One (1) sample was received without its original packaging.The sample was visually inspected at a distance of 12? under normal lighting to received unit, in order to detect any damage on the unit.During the visual inspection, it was found a hole in bag between the tape and bag.A random sample of 32 units was taken from process in order to verify that parts are free of workmanship defects and damaged.No discrepancies were found.After a review of the different verifications that are performed during the manufacturing process to detect damaged components, the most probable root cause is that damaged occurred after the product left the facility.Actions taken to mitigate the issue: as mitigation qalert (b)(4) was generated on 28/aug/18 to ensure that operators verify that breathing bags are free of holes and damaged.No product information has been provided to date.

• Brand Name: PORTEX GENERAL ANESTHESIA BAGS
• Type of Device: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section G): NULL
• MDR Report Key: 15708512
• MDR Text Key: 307026469
• Report Number: 3012307300-2022-26553
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• PMA/PMN Number: K172823
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 670003
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1