FDA.reportPublic FDA data

MAUDE MDR 8565372

MDR report key
8565372
Report number
1213809-2019-00486
Event key
0
Event type
3
Date of event
2019-04-12
Date received
2019-04-30
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
BDX BRETT WILKO
Address
9450 SOUTH STATE STREET SANDY UT 84070 US
Phone
801-801-8015
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1BD? ORAL DISPENSING SYRINGELIQUID MEDICATION DISPENSERBECTON DICKINSON MEDICAL SYSTEMSKYW3052108263594R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-04-3001. O

Event Narratives#

N

Patient 1

DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. (B)(6). INVESTIGATION SUMMARY: ONE PHOTO RECEIVED FOR THIS COMPLAINT. THE ACTUAL SAMPLE ASSOCIATED WITH THIS COMPLAINT WILL BE REQUIRED FOR FURTHER ANALYSIS IN ORDER TO IDENTIFY THE CONTAMINATION FOUND BY CUSTOMER. NO TESTS PERFORMED SINCE SAMPLES WERE NOT RECEIVED. A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT INVESTIGATION CONCLUSION: WE WERE NOT ABLE TO IDENTIFY THE FOREIGN MATTER FOUND SINCE THE ONE SAMPLE WAS NOT RECEIVED AND ANALYZED. ROOT CAUSE DESCRIPTION: THE POTENTIAL ROOT CAUSE FOR THE FOREIGN MATTER (FM) DEFECT FOUND CANNOT BE DETERMINED BASED ON PHOTOS PROVIDED, IT IS DIFFICULT TO DETERMINE IF THE FM FOUND IS ASSOCIATED WITH OUR MANUFACTURING PROCESSES BASED ON WHAT WE KNOW. THE ACTUAL SAMPLE IS REQUIRED TO IDENTIFY THE FM AND EVALUATE OTHER ASPECTS OF THE PRODUCT THAT COULD LEAD TO A BETTER UNDERSTANDING OF THE PRODUCT DEFECT FOUND AND THE SOURCE OF THE PROBLEM. THE SYRINGE COMPONENTS (BARREL, PLUNGER, STOPPER) ARE NOT EXPOSED TO ANY SOLID LUBRICANT DURING THE MANUFACTURING PROCESS: 1-MARKING, 2-ASSEMBLY, AND 3-PACKAGING. MEDICAL GRADE SILICONE IS ADDED TO THE INSIDE OF THE BARREL FOR PROPER FUNCTIONALITY OF THE SYRINGE. SILICONE IS AN INERT, NON-TOXIC MEDICAL SUBSTANCE USED AS A LUBRICANT FOR DISPOSABLE HYPODERMIC PRODUCTS. IT IS AN INTEGRAL PART OF THE SYRINGE, ENABLING IT TO PERFORM AS REQUIRED IN VARIOUS CLINICAL APPLICATIONS AND DOES NOT PRESENT A SAFETY OR EFFICACY ISSUE NOR DOES IT IMPACT PRODUCT FUNCTION. THE SILICONE APPLICATION PROCESS IS DESIGNED TO PROVIDE AN EVEN DISTRIBUTION OF SILICONE ON THE INTERIOR OF THE SYRINGE BARREL. SILICONE HAS BEEN IN USE IN THIS APPLICATION FOR OVER 20 YEARS. NO REPORTS ARE KNOWN OF ADVERSE CLINICAL EFFECTS ASSOCIATED WITH THESE PRODUCTS AND UNINTENTIONAL DELIVERY OF SILICONE FLUID LUBRICANT. ADDITIONALLY, A COMPLAINT REPORT FROM 2013 TO CURRENT WAS PERFORMED FOR P/N 305210, NO OTHER SIMILAR COMPLAINTS HAVE BEEN RECEIVED AS OF 04/23/2019. RATIONALE: NO CORRECTIVE ACTIONS ARE NECESSARY BASED ON THE DEFECTIVE RATE IDENTIFIED. BATCH 8263594 IS CONSIDERED IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS.

D

Patient 1

IT WAS REPORTED THAT FOREIGN RESIDUE WAS FOUND IN THE BD? ORAL DISPENSING SYRINGE BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CONTAMINATED SYRINGE WAS DISCOVERED PRIOR TO BEING USED, THEREFORE IT HAS BEEN DETERMINED THAT THIS DID NOT OCCUR AT OUR SITE. ONLY ONE SYRINGE HAS BEEN OBSERVED WITH THIS DEFECT FROM THIS BATCH AND IS NOT AVAILABLE TO BE RETURNED FOR INVESTIGATION. WE PERFORMED IN HOUSE TESTING ON THE SYRINGE AND THERE WAS NOT ENOUGH RESIDUE TO PERFORM SPECTRAL ANALYSIS BUT IT WAS POSITIVE FOR BIOBURDEN CONTENT.