MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2017-08-23 for LUMBAR PUNCTURE TRAY ADULT 22G X3.5 STRL 4306C manufactured by Carefusion, Inc.
[83480560]
(b)(4). Initial emdr submission. A follow up emdr will be submitted if additional information becomes available. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[83480561]
Customer stated via email: the vials are shattering and physicians are injuring their hands. Additional information received from customer 8/1/2017: (b)(6) asked me to pass along that two of our physicians have voiced concerns over the current stock of the carefusion adult lumbar puncture tray set. Specifically the glass lidocaine vial that's included. Several vials have shattered when the docs try to use them, resulting in injuries to the physicians. (b)(6) asked to look into a possible recall for this item. Cat: 4306c with lot no: 0000858285 with lidocaine vendor lot no: 566953a. Additional information received 03-aug-2017: it was two dr and two trays they both got laceration to finger. Both repaired with dermbond and bandaid but they did not want these trays again saying the lidocaine amp shattered instead of snapping off. Additional information received 22-aug-2017: initials, age, gender for each physician: (b)(6); (b)(6) y/o, male. Did you notice an absence of scoring on the lidocaine vials? No. Do you have any samples or photos to return for evaluation? No.
Patient Sequence No: 1, Text Type: D, B5
[107142309]
(b)(4). Follow up emdr submission for device evaluation. A sample was not returned for analysis. A device history record review was completed for lot 0000858285. A nonconformance was issued for a missing cap on a vial. This issue was reconciled and is unrelated to the reported failure. No issues pertaining to the reported failure mode were identified in the device history record report. Malfunctioning drug vials are likely the result of faulty material. A scar (supplier corrective action request) was issued to the supplier for this defect.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1625685-2017-00309 |
| MDR Report Key | 6813024 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-08-23 |
| Date of Report | 2017-10-27 |
| Date of Event | 2017-07-18 |
| Date Mfgr Received | 2017-07-31 |
| Date Added to Maude | 2017-08-23 |
| 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 | 400 EAST FOSTER RD |
| Manufacturer City | MANNFORD OK 74044 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 74044 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LUMBAR PUNCTURE TRAY ADULT 22G X3.5 STRL |
| Generic Name | NEEDLE, SPINAL, SHORT TERM |
| Product Code | MIA |
| Date Received | 2017-08-23 |
| Model Number | 4306C |
| Catalog Number | 4306C |
| Lot Number | 0000858285 |
| 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, INC |
| Manufacturer Address | 75 NORTH FAIRWAY DRIVE VERNON HILLS IL 60061 US 60061 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-08-23 |