MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1996-11-21 for BABY CARE UNIT PL12BCYHB manufactured by Allegiance-surgical Group.
[20525530]
During a delivery the physician observed meconium staining in the amniotic fluid. The physician tried to suction the infant using the 10 fr suction catheter contained in the kit. There was suction to the catheter but no suctioning from the infant was observed. The infant could have aspirated this fluid and caused aspirated pneumonia. Infant was transferred to the neonatal icu for observation and toxicology testing. No add'l treatment was necessary. Infant observed for ony 3-4 hours.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1043577-1996-00109 |
| MDR Report Key | 51712 |
| Report Source | 05 |
| Date Received | 1996-11-21 |
| Date of Event | 1996-10-01 |
| Date Mfgr Received | 1996-10-22 |
| Device Manufacturer Date | 1996-09-01 |
| Date Added to Maude | 1996-11-29 |
| 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 | 0 |
| 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 | BABY CARE UNIT |
| Generic Name | BABY CARE UNIT |
| Product Code | LRR |
| Date Received | 1996-11-21 |
| Model Number | PL12BCYHB |
| Catalog Number | PL12BCYHB |
| Lot Number | UNK |
| ID Number | NA |
| Operator | OTHER |
| Device Availability | N |
| Device Age | 1 MO |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 52372 |
| Manufacturer | ALLEGIANCE-SURGICAL GROUP |
| Manufacturer Address | 3031 NEVADA BLVD BLDG K CHARLOTTE NC 28273 US |
| Baseline Brand Name | BABY CARE KIT |
| Baseline Generic Name | BABY CARE KIT |
| Baseline Model No | PL12BCYHB |
| Baseline Catalog No | PL12BCYHB |
| Baseline ID | NA |
| Baseline Device Family | BABY CARE KIT |
| Baseline Shelf Life Contained | A |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K810242 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1996-11-21 |