MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-04-20 for AMNIOCENTESIS TRAY 20G X 3.5IN NEEDLE 4545A manufactured by Carefusion, Inc.
[43125989]
(b)(4) if additional information becomes available as follow up emdr will be submitted. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[43125990]
There has been 3 episodes where the vial in the kit shattered within the last 4 weeks. On (b)(6) 2016, a vial shattered and actually punctured the administrator. The reporter definitely believes there is a quality issue. The incident date reflects the first business day of the week the reporter believes the first episode occurred. On (b)(6) 2016; writer spoke with reporter via telephone. She states: received laceration, without need for intervention, ampule(s) appeared to be without defect or anomaly, blue scoring line noted denies any patient harm or impact. Lot number nor sample available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1625685-2016-00237 |
| MDR Report Key | 5591768 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-04-20 |
| Date of Report | 2016-04-06 |
| Date of Event | 2016-03-07 |
| Date Mfgr Received | 2016-04-06 |
| Date Added to Maude | 2016-04-20 |
| 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 Phone | 8473628063 |
| 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 | AMNIOCENTESIS TRAY 20G X 3.5IN NEEDLE |
| Generic Name | SAMPLER, AMNIOTIC FLUID (AMNIOCENTESIS TRAY) |
| Product Code | HIO |
| Date Received | 2016-04-20 |
| Model Number | 4545A |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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. Other | 2016-04-20 |