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

Catalog Number 008870

Device Problem Crack (1135)

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

Event Date 03/09/2020

Event Type  malfunction  

Manufacturer Narrative

A product was received and sent to the supplier for investigation.This is a supplied item; the device history record (dhr) is at the supplier.Evaluation of the product by the supplier determined that the damage occurred during shipments of single cartons of pre-pak's from the distributors to end users.Unpalletized prepak carton shipping procedures, has been provided to the manufacture several times over the last five years.This procedure details packaging the single packs of discs in an overpack with shipping popcorn.This will prevent damage to the pre-paks.The box the pre-packs are packaged in cartons that clearly states they are fragile.The reported issue was confirmed.The root cause of the reported issue was found to be in the shipping.Udi is unknown.Operator of device is unknown.Manufacturing site address is unknown.Pma/510k is unknown.No information has been provided to date this remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

Event Description

It was reported that upon opening the package the customer noticed both cases were cracked.No patient injury was reported.

• Brand Name: PORTEX ANESTHESIA BREATHING CIRCUIT
• Type of Device: CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
• Manufacturer (Section G): NULL
• MDR Report Key: 15416817
• MDR Text Key: 305713282
• Report Number: 3012307300-2022-19052
• Device Sequence Number: 1
• Product Code: CAI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 008870
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1