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.
[4020298]
The distributor reported that during incoming inspection a very long hair was noted to be contacting the introducer/packaged with the introducer.
Patient Sequence No: 1, Text Type: D, B5
[11412068]
(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 presence of a human hair in the peel-away sheath compartment. The evaluation was able to definitively identify the source of the identified fiber as human hair. It has been identified that this failure mode is not an isolated event. The shunt assemblies are manufactured in a controlled manufacturing environment that uses strict control over product movement into and out of the manufacturing room and requires specialty personal protective equipment for the manufacturing personnel to minimize the inadvertent transfer of debris. 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 results, the root cause was identified as improper technique for wearing of a hairnet by an assembly operator which led to inadvertent debris transfer from the assembly operator to the product. All applicable manufacturing and quality personnel will receive remedial training on the applicable procedures and techniques for proper wearing of hairnets. 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 | 1625685-2013-00064 |
| MDR Report Key | 3473256 |
| Report Source | 01,08 |
| Date Received | 2013-11-15 |
| Date of Report | 2012-09-18 |
| Date of Event | 2012-09-18 |
| Date Mfgr Received | 2012-11-29 |
| 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 | 2012-09-24 |
| Model Number | 42-2050 |
| Lot Number | 0000405742 |
| Operator | PHYSICIAN |
| 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 |