N
Patient 1
CUSTOMER HAS NOT RETURNED THE DEVICE TO THE MANUFACTURER FOR DEVICE EVALUATION. IF THE DEVICE BECOMES AVAILABLE AND IS RETURNED AND EVALUATED, THE MANUFACTURER WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVALUATION.
MAUDE MDR 6760902
- MDR report key
- 6760902
- Report number
- 3012307300-2017-01665
- Event key
- 0
- Event type
- 3
- Date of event
- 2017-07-13
- Date received
- 2017-08-02
- 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
- JENNIFER MENG
- Address
- 6000 NATHAN LANE NORTH MINNEAPOLIS MN 55442 US
- Phone
- 763-763-7633
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | PORTEX? CSECURE? SPINAL AND EPIDURAL NEEDLE ASSEMBLY - MINIPACK | SPINAL EPIDURAL ANESTHESIA KIT | SMITHS MEDICAL ASD, INC. | OFT | 100/491/716 | 3392516 | Y | * |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2017-08-02 | 0 |
Event Narratives#
D
Patient 1
IT WAS REPORTED THAT THE EPIDURAL CATHETER OF A PORTEX? CSECURE? SPINAL AND EPIDURAL NEEDLE ASSEMBLY - MINIPACK FRACTURED IN THE PATIENT DURING REMOVAL, WITH THE DISTAL 4.5CM REMAINING IN THE PATIENT'S BACK. THE PATIENT HAD A COMBINED SPINAL-EPIDURAL (CSE) FOR ANALGESIA DURING LABOR. THE EPIDURAL SPACE WAS LOCATED AT 5CM USING A STANDARD LOSS OF RESISTANCE TECHNIQUE, WITH 4CM THREADED INTO THE EPIDURAL SPACE. THE CSE PROCEDURE WAS PERFORMED AT THE FIRST ATTEMPT AND WAS UNCOMPLICATED, PROVIDING EFFECTIVE PAIN RELIEF IN LABOR, WITH SPONTANEOUS VAGINAL DELIVERY OCCURRING APPROXIMATELY AN HOUR AFTER CSE PROCEDURE. WHEN THE EPIDURAL CATHETER WAS REMOVED AFTER DELIVERY, THE EPIDURAL CATHETER WAS FOUND TO BE FRACTURED, WITH THE DISTAL 4.5CM IN THE PATIENT'S BACK. THERE WAS NOTHING TO SEE OR FEEL ON INSPECTION OF THE LOWER LUMBAR SPINE. THE AREA AROUND THE PATIENT'S BED WAS CAREFULLY INSPECTED FOR THE MISSING SEGMENT OF THE EPIDURAL CATHETER. THE EPIDURAL CATHETER DID NOT SHOW ANY SIGN OF BEING STRETCHED OR FRAYED. THERE WAS A 45 DEGREE CLEAN TRANSECTION 0.5CM BELOW THE 5CM MARK. THE PATIENT WAS THEN REFERRED TO NEUROSURGEON. AN MRI WAS PERFORMED TOGETHER WITH A PLAIN LUMBAR SPINE X-RAY. THE RETAINED FRAGMENT OF EPIDURAL CATHETER WAS NOT SEEN ON THE MRI SCAN OR PLAIN X-RAY. IT WAS DECIDED THAT NO FURTHER IMAGING OR INTERVENTION WOULD BE PROVIDED. NO PERMANENT INJURY WAS REPORTED.
N
Patient 1
PHOTOGRAPHS OF THE DEVICE WERE RECEIVED FOR INVESTIGATION. FROM THE PHOTOGRAPHS, IT WAS OBSERVED THAT THE TIP OF THE CLOSED END OF THE CATHETER WAS BROKEN. A MANUFACTURING REVIEW OF A SIMILAR DEVICE WAS PERFORMED AND NO DISCREPANCIES WERE FOUND. THE MOST PROBABLE ROOT CAUSES WERE ATTRIBUTED TO MANUFACTURING DEFICIENCY OR OUTSIDE CAUSES: THE TIP OF THE CATHETER WAS DAMAGED DURING THE END CLOSED FORMING OPERATION. THE DAMAGE IN THE CLOSED END OF THE CATHETER WAS NOT DETECTED PER VISUAL INSPECTION PERFORMED IN THE MANUFACTURING PROCESS. THE BROKEN CLOSED END OF THE CATHETER WAS ATTRIBUTED TO A POST MANUFACTURING SITUATION.