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.
[18567976]
The distributor reported that during incoming inspection hair-like matter and dust was found in packaging upon inspection of incoming shipment.
Patient Sequence No: 1, Text Type: D, B5
[18767916]
(b)(4). In response to an fda inspection (conducted (b)(4) 2013), carefusion 2200 initiated a capa investigation (capa (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: one (1) unopened sample was provided for evaluation. Evaluation of the complaint sample confirmed the reported failure mode. A review of complaint data identified that this failure mode is not an isolated event. A review of applicable manufacturing procedures noted the potential for debris to migrate from a manufacturing operator to the finished device. A device history review (dhr) for the listed manufacturing lot showed no recorded quality problems or rejections related to this incident. 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 | 1625685-2013-00050 |
| MDR Report Key | 3472779 |
| Report Source | 01,08 |
| Date Received | 2013-11-15 |
| Date of Report | 2009-12-01 |
| Date of Event | 2009-11-30 |
| Date Mfgr Received | 2010-02-15 |
| 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 | 2009-12-15 |
| Model Number | 42-2050 |
| Lot Number | L9N248 |
| Operator | OTHER |
| 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 |