FDA.reportPublic FDA data

MAUDE MDR 7818308

MDR report key
7818308
Report number
3011175548-2018-00923
Event key
0
Event type
3
Date of event
2018-08-13
Date received
2018-08-27
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
2
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Address
40 CONTINENTAL BLVD MERRIMACK NH 03054 US
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1CATHETER, 28 FR RIGHT ANGLECATHETER, CHOLANGIOGRAPHYATRIUM MEDICALGBZ81288128ME221275Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-08-270

Event Narratives#

N

Patient 1

WE ARE IN THE PROCESS OF PERFORMING THE INVESTIGATION AND WILL SUBMIT THE FOLLOW-UP REPORT ONCE THE EVALUATION IS COMPLETED.

D

Patient 1

REPORT RECEIVED STATED THAT A NURSE WAS OBTAINING PRODUCTS FROM CENTRAL SUPPLY STOCK FOR A CASE AND FOUND THORACIC CHEST TUBE CATHETERS THAT THE PACKAGING WAS UNSEALED ON ONE END.

N

Patient 1

THE THORACIC CATHETER WAS RECEIVED AND INSPECTED. THE BOTTOM SIDE OF THE CATHETER POUCH WAS FOUND TO BE UNSEALED. UPON FURTHER INSPECTION IT WAS DETERMINED THAT THERE WERE NO SIGNS THAT THE POUCH HAD BEEN ATTEMPTED TO BE SEALED. THERE WERE NO WITNESS LINES CREATED BY THE SEALER OR DEFORMATION OF THE FILM CAUSED BY THE HEAT OF THE SEALING PROCESS. THE PVC THORACIC CATHETERS ARE SUPPLIED TO ATRIUM BY A CONTRACT MANUFACTURER ((B)(4)), WHICH IS RESPONSIBLE FOR THE ASSEMBLY AND PACKAGING PROCESSES. ATRIUM RECEIVES THE PRODUCT AND PERFORMS AN AQL SAMPLING AND INSPECTION OF THE PACKAGED ASSEMBLY. THE INSPECTION INCLUDES VERIFICATION OF APPROPRIATE LABELING AND PACKAGING. REVIEW OF THE RECEIVING INSPECTION RECORDS FOR THIS LOT OF CATHETERS WERE FOUND TO HAVE MET SPECIFICATIONS. BASED ON THE CONFIRMATION OF THE COMPLAINT, ATRIUM MEDICAL HAS ISSUED A SUPPLIER CORRECTIVE ACTION REQUEST TO THE SUPPLIER OF THE CATHETERS. CLINICAL EVALUATION: THORACIC CATHETERS ARE STERILE, SINGLE USE, DISPOSABLE DEVICES AND ARE INTENDED TO FACILITATE THE EVACUATION OF AIR AND/OR FLUID FROM THE CHEST CAVITY OR MEDIASTINUM. A PACKAGE THAT IS UNSEALED WOULD BE EXPECTED TO BE NOTICED BEFORE IT WAS ENTERED INTO THE STERILE FIELD, AS IT WAS IN THIS CASE. IT WOULD REPRESENT A DELAY IN TREATMENT FOR THE PATIENT. THE INSTRUCTIONS FOR USE (IFU) STATES DO NOT USE IF THE DEVICE OR PACKAGING IS DAMAGED.

D

Patient 1

N/A.