MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-08-29 for JACKSON-PRATT SILICONE FLAT DRAIN 10MMX20CM SU130-1309 manufactured by Cardinal Health 200 Llc.
[53331502]
Patient Sequence No: 1, Text Type: N, H10
[53331503]
Pt had first post-op clinic visit. During attempt to remove 2 jp drains, they snapped off and portion remained in pt. Pt scheduled to undergo surgery the next day for removal. Pt underwent exploratory laparotomy and removal of retained drains under general anesthesia. No complications and pt discharged home. Per surgeon, drain was not caught in suture line and had not been damaged/melted by cautery. Stated saw no marks or issues with drain when surgically removed them. Stated no known reason for the drains to snap. The portion that broke off in clinic were not saved so only the portion in pt that were surgically removed available to send to manufacturer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5909841 |
| MDR Report Key | 5909841 |
| Date Received | 2016-08-29 |
| Date of Report | 2016-08-25 |
| Date of Event | 2016-08-18 |
| Report Date | 2016-08-25 |
| Date Reported to FDA | 2016-08-25 |
| Date Reported to Mfgr | 2016-08-25 |
| Date Added to Maude | 2016-08-29 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | JACKSON-PRATT SILICONE FLAT DRAIN 10MMX20CM |
| Generic Name | DRAIN, WOUND, CATHETER |
| Product Code | OTK |
| Date Received | 2016-08-29 |
| Catalog Number | SU130-1309 |
| Lot Number | P1504640 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | 16 DY |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDINAL HEALTH 200 LLC |
| Manufacturer Address | 1500 WAUKEGAN ROAD WAUKEGAN, IL 60085 US 60085 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-08-29 |