MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-12-23 for ARGYLE DELEE MUCUS TRAP 8888 257469 257469 manufactured by Sherwood Davis & Geck Global Product Assurance.
[74841]
The baby being deliverdd had meconium stained fluid. Upon delivery of the head on the perineum, the oralpharynged area was suctioned using the sherwood argyle delee mucus trap #8888 suction catheter. About 8cc of meconium stained fluid was removed. The baby was delivered and placed on the warmer. Rptr placed a laryngoscope blade into the baby's mouth to look at the mouth and vocal cord for any more meconium. As rptr attempted to suction the oralpharnged area with the sherwood catheter (the catheter was lying on its side. It is impossible to keep it up straight). The fluid was sucked up the tubing going to the filter, the filter plugged and shut off the suction to the catheter. On other catheters there is no filter and if fluid goes up the suction tubing, it would go directly to the suction bottle below the warmer. By having the filter clogged, rptr had to change the mucus trap in the middle of suctioning out the baby. By delaying the suctioning procedure, this could cause the baby to aspirate the meconium fluid down into their lungs thus causing meconium aspiration syndrome with possible pneumonia, pulmonary hypertension, and if very severe eventually could cause death. The co has been notified of this problem and thinks there is nothing wrong with their delee mucus trap.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 142604 |
| MDR Report Key | 142604 |
| Date Received | 1997-12-23 |
| Date of Report | 1997-12-18 |
| Report Date | 1997-12-18 |
| Date Reported to FDA | 1997-12-18 |
| Date Added to Maude | 1998-01-13 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RESPIRATORY THERAPIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARGYLE DELEE MUCUS TRAP |
| Generic Name | MUCUS TRAP |
| Product Code | BYZ |
| Date Received | 1997-12-23 |
| Model Number | 8888 257469 |
| Catalog Number | 257469 |
| Lot Number | 804878 |
| ID Number | CONTACT PERSON JANE ROZYCKI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 139078 |
| Manufacturer | SHERWOOD DAVIS & GECK GLOBAL PRODUCT ASSURANCE |
| Manufacturer Address | 444 MCDONNELL BL. HAZELWOOD MO 630422561 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Required No Informationntervention | 1997-12-23 |