MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-17 for DAVIS BRAIN RETRACTOR 1/2IN W 7-1/2IN NL1300 manufactured by Carefusion, Inc.
[73120386]
On 04apr2017, writer sent the customer an email acknowledging receipt of the complaint, providing the complaint tracking number and requested follow up information including as to if there was any patient impact related to this event. Writer provided contact information. Device not yet evaluated. If the device is evaluated a follow up will be sent.
Patient Sequence No: 1, Text Type: N, H10
[73120387]
Sales rep stated via email: they are not stating that the instrument was defective. They stated that the surgeon accidentally hit the retractor with the drill and shavings were then in brain which is why they are wanting information that is ok for the patient to go into the mri. No further information available.
Patient Sequence No: 1, Text Type: D, B5
[96735321]
(b)(4): one (1) nl1300 davis brain retractor 1/2 in w 7-1/2 in was reported as the complaint. The sample was not returned for evaluation, no pictures were sent for review, and no lot code was reported for the sample. It was reported that the malleable sample failed due to shavings being created from contact with the drill. The failure mode occurred during surgery, where the shavings were reported to be removed by surgical processes and possibly remain in the patient. Further complaint information was not provided, as well as, multiple contact attempts for the sample retrieval were completed. Full verification of the reported failure mode cannot be confirmed without sample/picture evaluation. For further investigations the material, function and properties of the nl1300 sample were reviewed. It should be known that the nl1300 is marketed as flexible silver, it is shaped as long rectangular thin spatula; 7. 5 inches l by? Inch w. It is intended to be used as a malleable retractor and can be bent to accommodate user requirements. The nl1300 material is a. 036 inch thick fine silver strip that is minimum 99. 9% silver (ag) it is annealed to provide the malleable function. There are no extensive finishing requirements from raw material to finished good. The product is buffed and etched as a final steps. It is not known how long the nl1300 sample was in use with the end user, the lot code was not reported. Conclusion(s): no sample was returned for evaluations and root cause determination. The reported broken issues and possible cause cannot be verified for final conclusion without sample review. Due to failure mode description from the initial report the customer discloses that the sample was hit with a drill causing the shavings to occur. The failure mode cannot be verified without the sample, but based upon the failure mode description it is probable that the failure mode was due to customer mis-use.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1923569-2017-00043 |
| MDR Report Key | 6496900 |
| Date Received | 2017-04-17 |
| Date of Report | 2017-06-19 |
| Date of Event | 2017-03-23 |
| Date Mfgr Received | 2017-06-12 |
| Date Added to Maude | 2017-04-17 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | ANNA WEHRHEIM |
| Manufacturer Street | 75 NORTH FAIRWAY DRIVE |
| Manufacturer City | VERNON HILLS IL 60061 |
| Manufacturer Country | US |
| Manufacturer Postal | 60061 |
| Manufacturer G1 | CAREFUSION, INC |
| Manufacturer Street | 5 SUNNEN DR |
| Manufacturer City | ST. LOUIS MO 63143 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 63143 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DAVIS BRAIN RETRACTOR 1/2IN W 7-1/2IN |
| Generic Name | INSTRUMENT, SURGICAL, NON-POWERED |
| Product Code | HAO |
| Date Received | 2017-04-17 |
| Model Number | NL1300 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION, INC |
| Manufacturer Address | 75 NORTH FAIRWAY DRIVE VERNON HILLS IL 60061 US 60061 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-04-17 |