MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-09-23 for TEBBETTS FIBEROPTC SS RETR 9CMX24MM BLDE 88-1087 manufactured by Carefusion.
[2194029]
Misuse of product customer states they connected cable to wrong port on light source so realized their error but caused patient burn.
Patient Sequence No: 1, Text Type: D, B5
[9350338]
"carefusion medical device complaints were previously handled by cardinal health under a transitional service agreement from (b)(6) 2009 until (b)(6) 2011. In retrospective review by carefusion representatives, it was determined that this event necessitates submission as an mdr in adherence with the federal codes of regulation. " the device was not received for evaluation. An attempt to contact the end user/customer for more information was made, and the customer could not be reached. A lot number was not provided and the device was not available for evaluation, a dhr review could not be performed. Root cause: user error - use of the incorrect light cable size, product labeling states that the device is for use with a 3. 5mm fiber-optic cable only. Historical corrective action summary: in (b)(6) 2009 every customer with record of purchase of the subject device from (b)(6) 2007 - (b)(6) 2009 was provided with a marketing bulletin concerning the proper care, handling and use of these devices, particularly the need to use the device with a 3. 55mm sized cable only. In addition, each customer was provided with a supplemental ifu (see item #3 below for details). In (b)(6) 2009 a training program was administered to all sales representatives of the company engaged in selling these devices to enable appropriate customer support and in-service, as appropriate. Creation of a supplemental ifu for inclusion in the device labeling beginning in (b)(6) 2009, followed by a fully updated and six language translated ifu issued in (b)(6) 2009. These ifus were updated to include a warning statement to ensure the use of the proper 3. 5mm fiber optic cable with the device and included several caution statements highlighting the proper use and care of the device. (b)(4)
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1038548-2011-00019 |
| MDR Report Key | 2262190 |
| Report Source | 05,06 |
| Date Received | 2011-09-23 |
| Date of Report | 2011-09-22 |
| Date of Event | 2010-03-25 |
| Date Mfgr Received | 2010-03-25 |
| Date Added to Maude | 2011-09-26 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JILL RITTORNO |
| Manufacturer Street | 1500 WAUKEGAN ROAD |
| Manufacturer City | MCGAW PARK IL 60085 |
| Manufacturer Country | US |
| Manufacturer Postal | 60085 |
| Manufacturer Phone | 8474737294 |
| Manufacturer G1 | CAREFUSION 2200, INC. SNOWDEN PENCER PRODUCTS |
| Manufacturer Street | 5175 SOUTH ROYAL ATLANTA DR |
| Manufacturer City | TUCKER 30084 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 30084 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TEBBETTS FIBEROPTC SS RETR 9CMX24MM BLDE |
| Generic Name | SNARE, RIGID SELF-OPENING |
| Product Code | FDJ |
| Date Received | 2011-09-23 |
| Model Number | 88-1087 |
| Lot Number | NO LOT GIVEN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION |
| Manufacturer Address | MCGAW PARK IL 60085 US 60085 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2011-09-23 |