MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 2013-11-19 for SHUNT DENVER ASCITES PAK DOUBLE VALVE 42-2050 manufactured by Carefusion.
[4017096]
The? Distributor reported that during incoming inspection, the following was found:? A stain larger than tappi 0. 8 on the surface of veinous tubing.
Patient Sequence No: 1, Text Type: D, B5
[11332871]
(b)(4). In response to an fda inspection (b)(4), 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 sample of catalog code 42-2050, lot number 0000545751, was submitted for evaluation. Examination of the complaint sample confirmed the presence of black imbedded debris in the venous tubing that is larger than 0. 8 mm2 tappi. A review of the manufacturing work instructions for the ascites double valve shunt assembly noted the inspection of the assembly is a visual inspection process. The work instructions include several indications ensuring the operator inspects the sealed trays adequately. A review of applicable manufacturing procedures and inspection methods identified specific manufacturing and inspection steps that may have contributed to the reported failure mode. The contribution of these manufacturing and inspection steps will be evaluated in capa investigation (b)(4). In addition, a review of all materials used in the assembly of the ascites double valve shunt assembly identified specific components that may have contributed to the reported failure mode. The contribution of these materials will also be evaluated in the capa investigation. A review of the device history record (dhr), raw material history files, and sterilization batch records for the listed manufacturing lot showed no recorded quality problems or rejections related to this incident. Based on the investigation results, it was determined that the following are the most probable root causes: some material transfer methods were not properly defined; several sources of debris existed from the manufacturing process; physical property of some of the materials used for manufacture of the product, generated static which promotes debris to become attached onto the components contained in the finished good trays; some raw materials were being supplied with debris as well as some finished good components; there were undefined specifications for debris between carefusion and raw material suppliers. Carefusion personnel were not following manufacturing procedures properly. The internal capa investigation is under execution to address this failure mode. All corrective and preventive actions (including manufacturing and quality plan improvements) will be implemented per the capa. In addition, preventive actions include, but are not limited to, developing debris standards according to current industry requirements.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1625685-2013-00086 |
| MDR Report Key | 3476867 |
| Report Source | 01,08 |
| Date Received | 2013-11-19 |
| Date of Report | 2013-07-18 |
| Date of Event | 2013-07-18 |
| Date Mfgr Received | 2013-11-18 |
| Date Added to Maude | 2014-02-26 |
| 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 | 2013-11-19 |
| Returned To Mfg | 2013-07-26 |
| Model Number | 42-2050 |
| Lot Number | 0000545751 |
| 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 | 2013-11-19 |