MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 2013-11-15 for SHUNT DENVER ASCITES PAK DOUBLE VALVE 42-2050 manufactured by Carefusion.
[4015502]
The distributor reported that foreign matter was noted inside the packaging upon inspection of product.
Patient Sequence No: 1, Text Type: D, B5
[11275719]
(b)(4). In response to an fda inspection (conducted 09 september 2013? 05 november 2013), carefusion 2200 initiated a capa investigation ((b)(4)). As part of the capa, a retrospective review of the complaints for? Debris? And? Contamination? For applicable devices was conducted. It was determined that this report necessitates submission as a medical device report (mdr). Evaluation summary: an evaluation of the complaint sample confirmed the presence of debris inside the secondary tray of the device. The debris was identified as a sliver of cardboard material. However, the investigation could not identify a specific source for the cardboard material. A review of applicable manufacturing procedures identified specific steps of the manual placement of all components inside the finished good tray. It was noted that assembly is performed in a controlled manufacturing environment and the quality plan for this product provides detailed requirements regarding debris on the product. A device history review (dhr) for the listed manufacturing lot showed no recorded quality problems or rejections related to this incident. Based on the investigation evidence, the root cause for this failure mode was identified as debris on a component during its placement in the finished good device. The manufacturing plant has also initiated a capa investigation ((b)(4)) to address the reported issue. All corrective and preventive actions (including manufacturing and quality plan improvements) will be implemented per the capa.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1625685-2013-00047 |
| MDR Report Key | 3472374 |
| Report Source | 01,08 |
| Date Received | 2013-11-15 |
| Date of Report | 2009-06-16 |
| Date of Event | 2009-06-15 |
| Date Mfgr Received | 2009-07-22 |
| Date Added to Maude | 2014-02-24 |
| 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 | JILL RITTORNO |
| Manufacturer Street | 75 NORTH FAIRWAY DRIVE |
| Manufacturer City | VERNON HILLS IL 60061 |
| Manufacturer Country | US |
| Manufacturer Postal | 60061 |
| Manufacturer Phone | 8473628056 |
| Manufacturer G1 | CAREFUSION 2200, 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 | SHUNT DENVER ASCITES PAK DOUBLE VALVE |
| Generic Name | SHUNT, PERITONEAL |
| Product Code | KPM |
| Date Received | 2013-11-15 |
| Returned To Mfg | 2009-06-25 |
| Model Number | 42-2050 |
| Lot Number | L9C293 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION |
| Manufacturer Address | 75 NORTH FAIRWAY DRIVE VERNON HILLS IL 60061 US 60061 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-11-15 |