MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2010-12-22 for CLAMP, UMBILICAL CORD, PLASTIC DYNJ04220 manufactured by Medline Industries, Inc..
[16368884]
The baby was handed off to the nurse, who noted that the cord was not clamped and was bleeding. The nurse immediately clamped the cord. The clamp was found in hazardous waste "kick bucket" securely fastened.
Patient Sequence No: 1, Text Type: D, B5
[16569714]
There has been no response from the account to multiple messages left. The medwatch report indicated that the baby was handed off to the nurse at the delivery. The nurse noted that the cord was not clamped and was bleeding. The nurse immediately clamped the cord with her hand until a cord clamp was placed on the cord. The physician stated that he had clamped the cord. The cord clamp was found in the hazardous waste 'kick bucket', securely fastened. The account did not determine a cause for the incident. The infant was observed in nicu due to blood loss and was transferred to the general nursery post transition. No sample was returned for eval. It is not known if physician error played a role in this incident or if the device did not function as intended. (b)(4). No trend exists for this issue. Without a sample to evaluate, no root cause has been determined. No corrective action is indicated at this time. However, due to the reported incident, a medwatch is being filed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1417592-2010-00076 |
| MDR Report Key | 1943028 |
| Report Source | 06 |
| Date Received | 2010-12-22 |
| Date of Report | 2010-12-17 |
| Date of Event | 2010-08-22 |
| Date Facility Aware | 2010-11-24 |
| Date Mfgr Received | 2010-11-24 |
| Date Added to Maude | 2012-03-08 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Manufacturer Contact | LARA SIMMONS |
| Manufacturer Street | ONE MEDLINE PLACE |
| Manufacturer City | MUNDELEIN IL 60060 |
| Manufacturer Country | US |
| Manufacturer Postal | 60060 |
| Manufacturer Phone | 8478372759 |
| Manufacturer G1 | MEDLINE INDUSTRIES, INC. |
| Manufacturer Street | ONE MEDLINE PLACE |
| Manufacturer City | MUNDELEIN IL 60060 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60060 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CLAMP, UMBILICAL CORD, PLASTIC |
| Generic Name | NONE |
| Product Code | FOD |
| Date Received | 2010-12-22 |
| Model Number | DYNJ04220 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES, INC. |
| Manufacturer Address | MUNDELEIN IL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-12-22 |