MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2009-12-09 for OB PACK V DYNJP6040 manufactured by Medline Industries, Inc..
[21287975]
It was reported that a cord clamp was not secure. The infant required a transfusion.
Patient Sequence No: 1, Text Type: D, B5
[21431703]
It was reported that a cord clamp failed and one infant required a blood transfusion. No further complication for the infant was reported. The facility stated there were two previous instances where a clamp did not hold. There was no negative consequences to the infants involved in the first two instances. All three instances involved the same physician. No actual samples were returned for eval. The facility has used these clamps for quite some time and states there have not been other similar instances. The physician was re-inserviced by the facility regarding use of the clamp. Samples from same lot were pulled from stock and tested. The clamps were found to be effective in occluding the flow of fluid and the issue could not be confirmed. No leaking was identified. And unused sample was also returned from the account. It was tested and no leaks were identified. We are unable to confirm the reported issue. However, due to the fact an infant required a blood transfusion, this mdr is being filed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1417592-2009-00060 |
| MDR Report Key | 1562880 |
| Report Source | 05,06 |
| Date Received | 2009-12-09 |
| Date of Report | 2009-12-01 |
| Date Facility Aware | 2009-11-03 |
| Date Added to Maude | 2010-09-29 |
| 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 | 3 |
| Manufacturer Contact | LARA SIMMONS |
| Manufacturer Street | ONE MEDLINE PL. |
| Manufacturer City | MUNDELEIN IL 60060 |
| Manufacturer Country | US |
| Manufacturer Postal | 60060 |
| Manufacturer Phone | 8478372759 |
| Manufacturer G1 | MEDLINE INDUSTRIES, INC. |
| Manufacturer Street | ONE MEDLINE PL. |
| 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 | OB PACK V |
| Generic Name | CORD CLAMP WITHIN |
| Product Code | HFW |
| Date Received | 2009-12-09 |
| Model Number | DYNJP6040 |
| Lot Number | A94298262 |
| 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 | 1. Required No Informationntervention | 2009-12-09 |