MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-07-20 for PEAN ARTERY FORCEPS 6-1/2IN CVD SU2760 manufactured by Carefusion, Inc.
[80777088]
(b)(4); device evaluation anticipated but not yet begun. Instrument to be returned to manufacturer for evaluation. Carefusion is the importer of record and owns the design, specification, regulatory pathway for this device. The manufacturer is (b)(4). Even though this was a product malfunction there was a potential for serious injury. If additional information is made available, a follow up will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[80777089]
Medical specialties - loose; maude report (b)(4) states: "mayo clamp used to clamp umbilicus following delivery fell off while transporting neonate following delivery. What was the original intended procedure? Mayo clamp following delivery pending placements of an umbilical clamp. Device usage problem: device malfunction - that is, the device did not do what it was supposed to do". Additional information provided (b)(6) 2017: the clamp has blood on it and is presently kept in a clear plastic bag. This was a newborn infant who had a mayo clamp applied following delivery yet prior to placement of an umbilical clamp. During transport from delivery, the may clamp used fell off. Obstetrician immediately placed another mayo clamp to stop bleeding. Estimated blood loss was 25-30 ml which is a significant volume for a newborn. Hemoglobin and hematocrit were followed closely. No blood products were required thereafter. Obstetrician immediately placed another mayo clamp to stop bleeding. It is unknown if the instrument was broken or loose. There were no retained objects.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423507-2017-00095 |
| MDR Report Key | 6729075 |
| Date Received | 2017-07-20 |
| Date of Report | 2017-07-20 |
| Date of Event | 2017-06-09 |
| Date Mfgr Received | 2017-07-05 |
| Date Added to Maude | 2017-07-20 |
| 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 Contact | ANNA WEHRHEIM |
| Manufacturer Street | 75 NORTH FAIRWAY DRIVE |
| Manufacturer City | VERNON HILLS IL 60061 |
| Manufacturer Country | US |
| Manufacturer Postal | 60061 |
| Manufacturer G1 | MEDICOR K |
| Manufacturer Street | H-4032 DEBRECEN |
| Manufacturer City | F |
| Manufacturer Country | HU |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PEAN ARTERY FORCEPS 6-1/2IN CVD |
| Generic Name | PEAN ARTERY FORCEPS |
| Product Code | GEN |
| Date Received | 2017-07-20 |
| Model Number | SU2760 |
| Catalog Number | SU2760 |
| Lot Number | NOT PROVIDED |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION, INC |
| Manufacturer Address | 75 NORTH FAIRWAY DRIVE VERNON HILLS IL 60061 US 60061 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-07-20 |