MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2014-04-30 for BROSELOW 7700PIN NA manufactured by Carefusion.
[4409801]
The et tube stylet is a tight fit for the et tube so the et tube was accidentally pulled out while trying to remove the stylet. Customer had to re-intubate and it took two people to remove the stylet to assure the patient wasn't extubated again. Discussion with t. Timothy, trauma program coord. And vital signs clinician (l. Spitaletto) on (b)(6) 2014. This was an emergency case, stylet and et tube were inspected and prepared for use. Lubricating jelly was used in application as is their standard practice. There was no difficulty inserting the stylet into the tube. Patient was easily intubated, ventilation was fine. This was not considered a difficult airway. A glidescope was not utilized. Difficulty was experienced on attempt to remove stylet. Upon removal of the stylet the patient was extubated. The patient was the re-intubated. After second intubation, one clinician held the et tube in place as the other clinician gently removed the stylet. The force of holding the et tube pushed the et tube in further than originally placed requiring a chest x-ray to fix/correct et tube placement. There was no patient injury and no intervention required beyond these events. Patient survived. The customer compared the old blue stylet previously kited in broselow to the new silver stylet and notes a slight visual difference in size (od). The blue stylets were also easier to insert and remove as they were smoother (less tacky). The silver stylet is more difficult to remove when bent into position.
Patient Sequence No: 1, Text Type: D, B5
[11896797]
(b)(4). Carefusion acquired ge vital signs on (b)(6) 2013. A retrospective review of all complaints post acquisition was performed. This complaint was identified as being mdr reportable by cfn standards and is being submitted to the fda. Upon carefusion's investigation, a follow up medwatch will be submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2242551-2014-00003 |
| MDR Report Key | 3836067 |
| Report Source | 00 |
| Date Received | 2014-04-30 |
| Date of Report | 2014-01-17 |
| Date of Event | 2014-01-22 |
| Date Mfgr Received | 2014-01-27 |
| Date Added to Maude | 2014-05-29 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JILL RITTORNO |
| Manufacturer Street | 75 N FAIRWAY DRIVE |
| Manufacturer City | VERNON HILLS IL 60061 |
| Manufacturer Country | US |
| Manufacturer Postal | 60061 |
| Manufacturer Phone | 8473628056 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BROSELOW |
| Generic Name | BROSELOW-INTUBATION MODULE |
| Product Code | OKI |
| Date Received | 2014-04-30 |
| Model Number | 7700PIN |
| Catalog Number | NA |
| Lot Number | 7900160 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION |
| Manufacturer Address | 20 CAMPUS RD. TOTOWA NJ 07512 US 07512 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-04-30 |