MAUDE Adverse Event Report: ST PAUL PORTEX OXYGEN AEROSOL ADAPTERS AND CONNECTORS; CONNECTOR, AIRWAY (EXTENSION)

Catalog Number 65-68-130PJP

Device Problem Device Damaged Prior to Use (2284)

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

Event Date 02/28/2022

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 before opening the package, the customer noticed it was damaged.There was no patient injury reported.

Manufacturer Narrative

Other text: d4 and g5 are unknown.No product information has been provided to date.This mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).A product sample was received for evaluation.Visual and functional testing were performed.No problems or issues were identified during this device history record review as a result of observation, a tear of 3 centimeters (cm) was confirmed.The results of the operation team survey are as follows.Only the barcode label was attached to this product, but since it was not subject to visual inspection, the detailed package has not been inspected.Regarding the packing form of this product, the box opens upward, and each box contains 10 pieces.Two pieces of four stations are staggered, and one piece of two stations was placed on top.The product package was handled in a connected state, it was unlikely that the operator's finger will touch the torn part, and the label affixing position and the torn part was parallel to each other, there was little possibility that pressure will be applied when the label was affixed.As a result of the above, the possibility of damage during label sticking work was extremely low.The reported event was confirmed.The root cause was possibility of package damage may have occurred after shipped or before it was received from the supplier.The information was shared with the operation team about the occurrence of this event and requested the supplier to investigate the eve.

• Brand Name: PORTEX OXYGEN AEROSOL ADAPTERS AND CONNECTORS
• Type of Device: CONNECTOR, AIRWAY (EXTENSION)
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 13929852
• MDR Text Key: 294123191
• Report Number: 3012307300-2022-05388
• Device Sequence Number: 1
• Product Code: BZA
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 65-68-130PJP
• Device Lot Number: 0000233390
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/06/2022
• 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