MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,07,08 report with the FDA on 2013-11-22 for UMBILICAL CORD CLAMP 84005182 manufactured by Unomedical Ltd..
[18368166]
A rep reported that a delivery room head nurse reported an umbilical cord clamp did not close entirely once it was sealed, hence it did not stop the bleeding from the umbilical cord.
Patient Sequence No: 1, Text Type: D, B5
[18402176]
Based on the available info, this event is deemed a reportable malfunction. The nurse reported they had to use another clamp of a different supplier in order to complete the procedure. The nurse reported that no damage or injury had occurred. No add'l pt/event details have been provided to date. A return sample for eval is not expected. Should add'l info become available, a f/u report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007966929-2013-00019 |
| MDR Report Key | 3578382 |
| Report Source | 01,05,06,07,08 |
| Date Received | 2013-11-22 |
| Date of Report | 2013-10-23 |
| Date of Event | 2013-10-17 |
| Date Mfgr Received | 2013-10-23 |
| Date Added to Maude | 2014-03-04 |
| 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 | MARY SZARO, ASSOCIATE DIRECTOR |
| Manufacturer Street | 200 HEADQUARTERS PARK DRIVE |
| Manufacturer City | SKILLMAN NJ 08558 |
| Manufacturer Country | US |
| Manufacturer Postal | 08558 |
| Manufacturer Phone | 9089042450 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UMBILICAL CORD CLAMP |
| Generic Name | OPERATION ACCESSORIES |
| Product Code | HFW |
| Date Received | 2013-11-22 |
| Model Number | 84005182 |
| Catalog Number | 84005182 |
| Lot Number | 654531 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNOMEDICAL LTD. |
| Manufacturer Address | ZAVODSKAYA STREET, 50 FANIPOL DZERZHINSK DISTRICT MINSK REGION 222750 BO 222750 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-11-22 |