FDA.reportPublic FDA data

MAUDE MDR 4936479

MDR report key
4936479
Report number
3004365956-2015-00196
Event key
0
Event type
3
Date of event
2015-07-01
Date received
2015-07-23
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
JASMINE BROWN
Address
3015 CARRINGTON MILL BLVD MORRISVILLE NC 27560 US
Phone
919-919-9193
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1DEK BL MF 0 FX45 2N 48" BARDSUTURETELEFLEX MEDICALOVNDEK200R *

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12015-07-230

Event Narratives#

D

Patient 1

ALLEGED EVENT: DURING A SACRO SPINAL FIXATION PROCEDURE, THE BULLET BROKE FROM THE SUTURE AND COULD NOT BE REMOVED FROM THE PATIENT. THE PATIENT'S CONDITION WAS REPORTED AS UNKNOWN.

N

Patient 1

(B)(4). THE DEVICE HISTORY RECORD OF BATCH NUMBER 74F1401435 HAS BEEN REVIEWED AND NO ISSUES OR DISCREPANCIES WERE FOUND WHICH COULD POTENTIALLY RELATE TO THIS COMPLAINT. THE DEVICE HISTORY REVIEW SHOWS THAT THE PRODUCT WAS ASSEMBLED AND INSPECTED ACCORDING TO OUR SPECIFICATIONS. VISUAL INSPECTION WAS PERFORMED USING THE PICTURE ATTACHED TO THIS COMPLAINT, PICTURES REFLECTS A DETACHED BULLET. A FUNCTIONAL INSPECTION OF THE PRODUCT INVOLVED IN THE COMPLAINT COULD NOT BE CONDUCTED SINCE THE PRODUCT WAS NOT RETURNED. THE CUSTOMER COMPLAINT IS CONFIRMED BASED ON THE PICTURE PROVIDED BY CUSTOMER. THE ROOT CAUSE IS UNKNOWN THEREFORE, CORRECTIVE ACTION CANNOT BE IMPLEMENTED. THE MANUFACTURER WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.

N

Patient 1

(B)(4). PRODUCT CODE DEK200 WAS RECEIVED; ONLY THE BULLET SECTION WAS RETURNED, THE SUTURE IS MISSING. SAMPLE WAS NOT RETURNED IN ITS ORIGINAL PACKAGING. PROCESS LINE WAS VERIFIED, AND IT WAS REVIEWED THAT THE PROCESS LINE HAS ALL THE STANDARDS TO ASSURE ALL CODES ARE MANUFACTURED ON THE RIGHT CONDITIONS. THIS COMPONENT (THREAD) PN: 123074, LOT: 74A1400183, DYE LOT: 74A1400123 ARE NOT MANUFACTURED AT TELEFLEX (B)(4), IT COMES FROM A SUPPLIER (B)(4). CUSTOMER COMPLAINT IS CONFIRMED BASED ON THE CONDITION OF THE SAMPLE RECEIVED. PHOTOS OF SAMPLE WILL BE SENT TO SUPPLIER IN ORDER TO DEFINE ROOT CAUSE AND CORRECTIVE ACTIONS. ACTIONS TO BE TAKEN ARE LISTED BELOW: DETERMINE ROOT CAUSE. RESPONSIBLE:(B)(4). DUE DATE: (B)(4) 2015.

D

Patient 1

ALLEGED EVENT: DURING A SACRO SPINAL FIXATION PROCEDURE, THE BULLET BROKE FROM THE SUTURE AND COULD NOT BE REMOVED FROM THE PATIENT. THE PATIENT'S CONDITION WAS REPORTED AS UNKNOWN.

N

Patient 1

(B)(4). ACCORDING THE PICTURE PROVIDED; THE CORRECT LOT NUMBER IS 74F1401435 INSTEAD OF THE LOT NUMBER REPORTED IN DESCRIPTION COMPLAINT (B)(4). FURTHERMORE, THE LOT NUMBER 74F1401433 IS NOT A VALID NUMBER IN NUEVO LAREDO FACILITY.

D

Patient 1

ALLEGED EVENT: DURING A SACRO SPINAL FIXATION PROCEDURE, THE BULLET BROKE FROM THE SUTURE AND COULD NOT BE REMOVED FROM THE PATIENT. THE PATIENT'S CONDITION WAS REPORTED AS UNKNOWN.

N

Patient 1

(B)(4). 1 SAMPLE OF PRODUCT CODE DEK200 WAS RECEIVED; ONLY THE BULLET SECTION WAS RETURNED, THE SUTURE IS MISSING. SAMPLE WAS NOT RETURNED IN ITS ORIGINAL PACKAGING. PROCESS LINE WAS VERIFIED, AND IT WAS REVIEWED THAT THE PROCESS LINE HAS ALL THE STANDARDS TO ASSURE ALL CODES ARE MANUFACTURED ON THE RIGHT CONDITIONS. THIS COMPONENT (THREAD) PN: 123074, LOT: 74A1400183, DYE LOT: 74A1400123 ARE NOT MANUFACTURED AT TELEFLEX (B)(4), IT COMES FROM A SUPPLIER (B)(4). PHOTOS OF SAMPLE WERE SENT TO VENDOR IN ORDER TO DEFINE ROOT CAUSE AND CORRECTIVE ACTIONS, PER VENDOR ANSWER: NO ISSUES RELATED TO THEIR PROCESS WERE IDENTIFIED, THEREFORE; A ROOT CAUSE AND CORRECTIVE ACTION CANNOT BE DEFINED.

D

Patient 1

ALLEGED EVENT: DURING A SACRO SPINAL FIXATION PROCEDURE, THE BULLET BROKE FROM THE SUTURE AND COULD NOT BE REMOVED FROM THE PATIENT. THE PATIENT'S CONDITION WAS REPORTED AS UNKNOWN.