FDA.reportPublic FDA data

MAUDE MDR 9656250

MDR report key
9656250
Report number
9616656-2020-00068
Event key
0
Event type
3
Date of event
2020-01-11
Date received
2020-02-01
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 PEN NDL 32G 4MMPEN NEEDLEBECTON DICKINSON AND CO.NSC3205558352806R *

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-02-0101. O

Event Narratives#

N

Patient 1

INVESTIGATION SUMMARY: COMPLAINT EVALUATION / COMPLAINT HISTORY CHECK FOR THE EVENT(S) THAT OCCURRED. NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED OCCURRENCE: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT FOR NEEDLE STICK & NEEDLE THROUGH SHIELD ON LOT # 8352806. A LOT HISTORY REVIEW WAS CARRIED OUT AND NO RELATED NON CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS PACKAGED LOT CONCLUDING ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS INVESTIGATION CONCLUSION: UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER?S INDICATED FAILURE AS NO SAMPLES OR PHOTOS WERE RETURNED COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. ROOT CAUSE DESCRIPTION: ROOT CAUSE CANNOT BE DETERMINED RATIONALE: BASED ON THE INVESTIGATION, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME.

D

Patient 1

IT WAS REPORTED THAT DURING USE THE BD PEN NDL 32G 4MM THERE WAS A NEEDLE STICK INJURY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: AHS MDIP REPORT. INCIDENT OR PROBLEM INFORMATION: AHS MDIP REFERENCE NUMBER (ID): (B)(4), DATE OF INCIDENT (YYYY-MM-DD): (B)(6) 2020, SITE NAME/LOCATION: (B)(6) MEDICAL CENTRE, LEVEL OF HARM: POTENTIAL FOR HARM, AHS OPTIONAL REPORT TO CMDSNET (HEALTH (B)(4)): YES. INCIDENT DETAILS: WHILE USING A BD STERILE INSULIN NEEDLE (32G X 4MM WITH GREEN CAP), WRITER ATTEMPTED TO RECAP THE NEEDLE AFTER USE. WHILE RECAPPING, THE NEEDLE DEFLECTED OFF THE INSIDE OF THE CAP, AND THEN PUNCTURED THE GREEN SAFETY CAP. THE WRITER DID NOT NOTICE THAT THE NEEDLE HAD NOT RECAPPED PROPERLY AND WHEN ATTEMPTED TO REMOVE THE NEEDLE FROM THE PEN A NEEDLE STICK INJURY OCCURRED. UPON INSPECTION OF THE GREEN CAP THE WRITER NOTICED THAT THE DESIGN HAD BEEN CHANGED, AND IS NOW FLARED AT THE END, AND THIS IS LIKELY WHAT THE NEEDLE DEFLECTED OFF OF. WHO WAS AFFECTED? HEALTH CARE PROFESSIONAL. FREQUENCY OF PROBLEM: FIRST TIME.