MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION PNEUMOSTAT CHEST DRAIN VALVE; BOTTLE, COLLECTION, VACUUM

Model Number 16100

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/23/2015

Event Type  malfunction  

Manufacturer Narrative

We are in the process of performing the investigation and will submit the follow-up report once the evaluation is completed.

Event Description

The event occurred while the physician was teaching a relative of the patient on how to evacuate the drain from the device using a luer lock 50cc syringe.When the syringe was inserted the needleless access connector (nac) broke off and stayed on the end of the syringe.Product was not used on the patient and there was no harm to patient.

Manufacturer Narrative

The unit was not returned for analysis.The picture provided indicates that the lower body nozzle material broke.There is no indication that the weld joint of the needless access connector (nac) separated.Pneumostat units have the weld of the nac tested during the welder setup and periodically during the run to meet a defined sample size based on the lot quantity.This also applies forces to the nozzle that would cause a failure if there were a material defect.If significant additional force (above the axial load limit) is applied, the nozzle can break below the weld joint.A device history record review was performed and the device was found to have met all specifications.Conclusion: it is possible that the applied force to the unit exceeded the established design limit resulting in breakage of the nozzle section.Without having the actual device to evaluate it is difficult to determine the actual root cause.

Manufacturer Narrative

The unit was returned for analysis.Evaluation of the break area confirms the previous conclusion.There is no indication that the weld joint of the needless access connector (nac) separated.

• Brand Name: PNEUMOSTAT CHEST DRAIN VALVE
• Type of Device: BOTTLE, COLLECTION, VACUUM
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; hudson NH 03051
• Manufacturer (Section G): ATRIUM MEDICAL CORPORATION; 5 wentworth drive; hudson NH 03051
• Manufacturer Contact: lori gosselin ; 40 continental blvd; merrimack, NH 03054-4929 ; 6038645366
• MDR Report Key: 5022380
• MDR Text Key: 23848450
• Report Number: 1219977-2015-00240
• Device Sequence Number: 1
• Product Code: KDQ
• Combination Product (y/n): N
• Reporter Country Code: RP
• PMA/PMN Number: K984496
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 08/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 02/28/2020
• Device Model Number: 16100
• Device Catalogue Number: 16100
• Device Lot Number: 221702
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/08/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/05/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 69 YR