MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION DRAINS ACCESSORIES - OTHER; BOTTLE, COLLECTION, VACUUM

Model Number 19927

Device Problem Packaging Problem (3007)

Patient Problems Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/31/2021

Event Type  malfunction  

Manufacturer Narrative

On completion of the investigation a follow up report will be submitted.

Event Description

Customer received only one of 25 units of box originally containing 25 units of product.Full box has been opened and only one of the units in the box has been sent.This means that the sterile box has been broken and a non-sterile unit has been sent to customer.

Event Description

N/a.

Manufacturer Narrative

It was reported that the customer ordered 25 of part 19927 (connector luer-lock w/tube) and received a box with only 1.They reported that the box appeared to have already been opened and so in addition to 24 of the 25 devices being missing, they are concerned the remaining part was no longer sterile.They provided a picture of the part they received and the box it was received in.Atrium has no record of shipping product to the complainant, so they most likely acquired the device from a distributor.Furthermore, the box pictured is not the carton that 25 of the pouches would have been packaged in, so this does not appear to be the original packaging that atrium would have shipped the product in.Additionally, the carton that these products are shipped in is not a sterile barrier.The pouch around each individual device is the sterile barrier.However, as the pouch was removed from its shelf box and repackaged, the integrity of its seal cannot be guaranteed.The outer packaging does not appear to be from atrium and it is not known why the customer did not receive the whole shipment they ordered.Three attempts were made to contact the customer in order to gather more information but the customer never responded.There was no patient involvement in this case and it was not reported that this caused any delay in treatment of a patient.Based on the information provided by the complainant and gathered during the investigation, it can be confirmed that the product was nonconforming when the complainant received it due to the device being shipped individually and not in its original packaging provided by atrium.The nonconformance appears to have resulted from a distributor repackaging the device.The root-cause of this complaint is third party service.The dhr was reviewed and found no nonconformance or anomalies in manufacturing or packaging of the device.Complaint trending did not identify any excursions that require a corrective action request.The complaint history review did not identify any related complaints.The review of cars/capas did not identify any cars or capas related to this complaint.A recurring lot number review did not find any other complaints involving lot 468104.H3 other text: device not available for return.

• Brand Name: DRAINS ACCESSORIES - OTHER
• Type of Device: BOTTLE, COLLECTION, VACUUM
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH
• Manufacturer (Section G): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH
• Manufacturer Contact: lori gosselin ; 40 continental blvd; merrimack, NH
• MDR Report Key: 12023886
• MDR Text Key: 262400633
• Report Number: 3011175548-2021-00667
• Device Sequence Number: 1
• Product Code: KDQ
• UDI-Device Identifier: 00065086219927
• UDI-Public: 0065086219927
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/02/2024
• Device Model Number: 19927
• Device Catalogue Number: 19927
• Device Lot Number: 468104
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/22/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/08/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1