MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION DRAINS OASIS SINGLE; BOTTLE, COLLECTION, VACUUM

Model Number 3600-100

Device Problem Component Missing (2306)

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

Event Type  malfunction  

Event Description

Customer reported: "we had an isolated event in the op block.At the beginning of the week, an atrium oasis drainage was taken from stock, but it could not be used because the blue tip to connect the suction was missing." device was discarded and another one was used for the patient.So no harm to any patient.

Manufacturer Narrative

Upon completion of the investigation into this event a follow up report will be submitted.

Manufacturer Narrative

Investigation summary: this complaint reports that the hospital opened an oasis drain (p/n 3600-100, l/n 497136) from their inventory, but were unable to use it because the blue nozzle used to connect the drain to suction was missing.No further description of the drain was provided.No pictures were provided.The drain has not been returned for investigation.Additional information was requested about the incident and the customer replied that no device, packaging, or pictures are available for evaluation.They stated that this incident resulted in a 5 minute delay to treatment and that so far no other devices have been found to be missing nozzles.They also indicated that the blue nozzle was noticed to be missing immediately upon unwrapping the drain and that the water bulb was attached to the back of the drain.A dhr review was completed for lot 497136 and no anomalies in manufacturing were identified.An ncr query was completed for lot 497136 and no ncrs were identified.It was found that the welding machine used to weld the suction nozzles to this lot failed its next calibration after lot 497136 was manufactured.This was determined be due to a faulty part which triggered an error and an alarm when that error occurred so it is not believed that nonconforming devices went unnoticed as a result.A review of ncrs for the past 2 years found one related to this complaint in which an operator found a nozzle that was not properly welded in place during qc inspection.The ifu provides adequate instructions for use of the device.It instructs the user not to use a device if it is damaged.Complaint trending found that the actual occurrence level did not exceed the anticipated occurrence level.No excursions were identified.A complaint history review was completed which found no similar complaints.A recurring lot number report was completed for lot 497136 which did not identify any other complaints involving this lot.A review of crs/capas found one cr, 948364, related to this complaint.That cr was opened in response to the effectiveness check of capa 579593 not demonstrating effectiveness.Capa 579593 was opened to address issues of missing components from drains.Due to a lack of evidence provided by the customer, neither the complaint nor a device nonconformance can be confirmed.However the problem described in the report is one that is known to be a potential nonconformance.The root-cause of this complaint is manufacturing - assembly.This complaint investigation will be escalated to cr 948364.H3 other text : device not available for return.

Event Description

N/a.

• Brand Name: DRAINS OASIS SINGLE
• 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: 18371456
• MDR Text Key: 331205639
• Report Number: 3011175548-2023-00205
• Device Sequence Number: 1
• Product Code: KDQ
• UDI-Device Identifier: 00650862110012
• UDI-Public: 00650862110012
• Combination Product (y/n): N
• Reporter Country Code: LU
• PMA/PMN Number: K043140
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 01/29/2024

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: Health Professional
• Device Model Number: 3600-100
• Device Catalogue Number: 3600-100
• Device Lot Number: 497136
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/08/2023
• Initial Date FDA Received: 12/21/2023
• Supplement Dates Manufacturer Received: 01/26/2024
• Supplement Dates FDA Received: 01/30/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/14/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNKNOWN.