MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-05-19 for F5 DIALYZER FINISHED ASSY 0500162R manufactured by Ogden Manufacturing.
[2019979]
While patient was receiving her hemodialysis treatment, the nurse noticed blood leaking from the venous header end cap. It was reported that the estimated blood loss was 10 ml. The nurse reported that the header end cap was not tightly sealed and that they tried tightening it. They believe this was the cause of the blood leak. The nurse said that the patient is fine. This patient did complete the entire treatment after this event with use of new product without further incident. There is no reported ill effect or medical treatment given. A sample is available for an evaluation. The patient was discharged to her home when the treatment was complete.
Patient Sequence No: 1, Text Type: D, B5
[9131890]
(b)(6).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1713747-2011-00012 |
| MDR Report Key | 2117139 |
| Report Source | 05,06 |
| Date Received | 2011-05-19 |
| Date of Report | 2011-05-19 |
| Date of Event | 2011-04-22 |
| Date Facility Aware | 2011-04-22 |
| Report Date | 2011-05-19 |
| Date Reported to FDA | 2011-05-19 |
| Date Reported to Mfgr | 2011-04-22 |
| Date Mfgr Received | 2011-04-22 |
| Device Manufacturer Date | 2010-09-01 |
| Date Added to Maude | 2011-08-01 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Street | 920 WINTER ST. |
| Manufacturer City | WALTHAM MA 02451 |
| Manufacturer Country | US |
| Manufacturer Postal | 02451 |
| Manufacturer Phone | 7816999070 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | F5 DIALYZER FINISHED ASSY |
| Generic Name | DIALYZER |
| Product Code | MSE |
| Date Received | 2011-05-19 |
| Model Number | NA |
| Catalog Number | 0500162R |
| Lot Number | 10LU04012 |
| ID Number | NA |
| Device Expiration Date | 2013-09-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 7 MO |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OGDEN MANUFACTURING |
| Manufacturer Address | OGDEN UT US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-05-19 |