MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2010-10-04 for JACKSON-PRATT DRAIN UNK NA manufactured by C.r. Bard, Inc..
[1466510]
The patient is a (b)(6), female, admitted to the medical center on (b)(6), 2010 for treatment related to a probable ovarian mass. On (b)(6), 2010, the patient underwent an exploratory laparotomy. A jackson-pratt drain was placed during the operation. On (b)(6), 2010, a nursing unit manager reported by phone that a physician attempted to pull the jackson-pratt drain from the patient's abdomen and the tube broke. The retained fragment retracted requiring surgical removal. The physician reported that she did not pull the drain any harder than usual for removing these drains. She has pulled many of them.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1862205 |
| MDR Report Key | 1862205 |
| Report Source | 99 |
| Date Received | 2010-10-04 |
| Date of Report | 2010-10-01 |
| Date of Event | 2010-09-27 |
| Date Facility Aware | 2010-09-27 |
| Report Date | 2010-09-27 |
| Date Reported to FDA | 2010-10-01 |
| Date Reported to Mfgr | 2010-10-01 |
| Date Added to Maude | 2010-10-13 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | JACKSON-PRATT DRAIN |
| Generic Name | BULB DRAIN |
| Product Code | JCY |
| Date Received | 2010-10-04 |
| Model Number | UNK |
| Catalog Number | NA |
| Lot Number | UNK |
| ID Number | REF 072210 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | NA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | C.R. BARD, INC. |
| Manufacturer Address | COVINGTON GA 30014 US 30014 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2010-10-04 |