MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2001-07-25 for 32-1328NT CLEAR GRIP SYRINGE NARROW-TIP manufactured by Deroyal Industries, Inc.
[19237894]
Upon attempting to use the bulb syringe to suction nasal secretions, the bulb collapsed and would not re-inflate. This has happened repeated times, each with a new bulb syringe. The product is available for eval.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1046367-2001-00040 |
| MDR Report Key | 344786 |
| Report Source | 06 |
| Date Received | 2001-07-25 |
| Date of Report | 2001-07-20 |
| Date of Event | 2001-06-16 |
| Date Mfgr Received | 2001-06-22 |
| Date Added to Maude | 2001-08-03 |
| 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 | 0 |
| Manufacturer Street | 200 DEBUSK LANE |
| Manufacturer City | POWELL TN 37849 |
| Manufacturer Country | US |
| Manufacturer Postal | 37849 |
| Manufacturer Phone | 8659387828 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 32-1328NT CLEAR GRIP SYRINGE NARROW-TIP |
| Generic Name | 7N4 WIDE BULB SYRINGE |
| Product Code | KCP |
| Date Received | 2001-07-25 |
| Model Number | NA |
| Catalog Number | 32-1328NT |
| Lot Number | 206146 |
| ID Number | NA |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 334110 |
| Manufacturer | DEROYAL INDUSTRIES, INC |
| Manufacturer Address | 200 DEBUSK LANE POWELL TN 37849 US |
| Baseline Brand Name | DEROYAL |
| Baseline Generic Name | ENT BLULB SYRINGE |
| Baseline Model No | NA |
| Baseline Catalog No | 32-1328NT |
| Baseline ID | NA |
| Baseline Device Family | CLEAR GRIP SYRINGE NARROW TIP |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2001-07-25 |