MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-11-22 for GROOVED DIRECTOR W/PROBE END &TONGUE TIE SU10830500 manufactured by Carefusion.
[1649263]
Tip broke off in patient. Procedure was in (b)(6) 2010 and it was found today, (b)(6) 2010 after patient complained of pain they were experiencing.
Patient Sequence No: 1, Text Type: D, B5
[8898643]
An investigation was initiated into the matter of, "broken tip" during use. The effected instrument was not received for evaluation; the effected instrument is crucial for a complete and accurate analysis of the concern. A review of trend reports over the last 5 years has revealed no previous incidents of any nature. If the sample is returned in the future, a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[8937048]
The effected instrument was not received for evaluation; however, the remaining tip portion of the effected instrument was available for review by our representative in (b)(4) 2011. During the investigation our team identified the following issues: we were unable to confirm the broken instrument was a v. Mueller product. The broken piece of the instrument reviewed had no identification markings that would allow us to identify the product code, lot code, or manufacturer. During the on-site evaluation of the remaining instruments provided by the hospital representatives, it was observed that there were samples from another company other than v. Mueller. Some of the instruments reviewed showed signs of an instrument that was manipulated and straightened several times. This instrument is not meant to be manipulated. The pictures obtained in the investigation were forwarded to the manufacturer along with a representative sample of the product code. Without the physical sample of the involved item to review and the limited level of detail of the pictures provided to them, the manufacturer is unable to determine several important aspects needed to determine the root cause of the failure, including whether this is an instrument they manufactured and when it was manufactured. The only way the manufacturer was able to produce a similar defect was to bend the item at the weld, which is considered misuse of the item. The manufacturer stated that this instrument was not meant to be bent. A review of trend reports over the last 5 years along with a complete evaluation of the instrument history has revealed no previous incidents of any nature.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1423507-2010-00045 |
| MDR Report Key | 1904546 |
| Report Source | 05 |
| Date Received | 2010-11-22 |
| Date of Report | 2010-11-22 |
| Date of Event | 2010-02-26 |
| Date Mfgr Received | 2010-10-26 |
| Date Added to Maude | 2010-11-30 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MICHELE DONATICH |
| Manufacturer Street | 1430 WAUKEGAN ROAD |
| Manufacturer City | MCGAW PARK IL 60085 |
| Manufacturer Country | US |
| Manufacturer Postal | 60085 |
| Manufacturer Phone | 8478876412 |
| Manufacturer G1 | CAREFUSION 2200, INC |
| Manufacturer Street | 1500 WAUKEGAN ROAD |
| Manufacturer City | WAUKEGAN 60085 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60085 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GROOVED DIRECTOR W/PROBE END &TONGUE TIE |
| Generic Name | DIRECTOR WITH PROBE |
| Product Code | FGM |
| Date Received | 2010-11-22 |
| Model Number | SU10830500 |
| Catalog Number | SU10830500 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2010-11-22 |