MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-06-13 for MEDLINE UMBILICAL CORD CLAMP DYNJ04229 manufactured by Medline Industries, Inc.
[77419802]
Patient Sequence No: 1, Text Type: N, H10
[77419803]
Umbilical cord clamp being found slipped off/ not maintaining clamp. This is resulting in bleeding from umbilical cords. Three events reported thus far. Manufacturer response for steri-kit identification/umbilical clamp, (brand not provided) (per site reporter): birthplace manager notified rep. First response was that staff not securing properly. However, after talking with another facility and their similar issues, our manager has determined that it is not that staff were not securing properly, but a true issue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6636294 |
| MDR Report Key | 6636294 |
| Date Received | 2017-06-13 |
| Date of Report | 2017-06-07 |
| Date of Event | 2017-06-01 |
| Report Date | 2017-06-07 |
| Date Reported to FDA | 2017-06-07 |
| Date Reported to Mfgr | 2017-06-07 |
| Date Added to Maude | 2017-06-13 |
| 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 |
| 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 | MEDLINE UMBILICAL CORD CLAMP |
| Generic Name | DEVICE, OCCLUSION, UMBILICAL |
| Product Code | FOD |
| Date Received | 2017-06-13 |
| Catalog Number | DYNJ04229 |
| Lot Number | 16AA0966 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES, INC |
| Manufacturer Address | 1204 TOWNLINE RD. 1 MEDLINE PLACE MUNDELEIN IL 60060 US 60060 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-06-13 |