MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-27 for SYRINGE ORAL 10ML CLEAR 305219 manufactured by Becton Dickinson Medical Systems.
[137527191]
Date of event: unknown. The date received by manufacturer has been used for this field. Device expiration date: unknown. Device manufacture date: unknown. Investigation summary: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident. No root cause can be determined as no samples were received. The lot number is unknown, therefore device history record review (dhr) or quality notification review (qn) could not be performed. Investigation conclusion: unconfirmed: bd was not able to confirm the customer? S indicated failures. Root cause description: no root cause can be determined as no samples were received.
Patient Sequence No: 1, Text Type: N, H10
[137527192]
It was reported that over 10 days of use the markings on a syringe oral 10ml clear came off. Customer stated, "complaint that i experienced recently as my son was taking antibiotics and we were using the 10ml oral bd syringe to draw up the liquid. Over the course of the 10 day antibiotic use we were only washing the syringe with regular dish soap between uses. By the mid-way through the prescription almost all of the markings had come off the syringe so that we were guessing on where the 10ml line appeared. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1213809-2019-00283 |
| MDR Report Key | 8373931 |
| Date Received | 2019-02-27 |
| Date of Report | 2019-02-14 |
| Date of Event | 2019-02-06 |
| Date Mfgr Received | 2019-02-06 |
| Date Added to Maude | 2019-02-27 |
| 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 | BDX BRETT WILKO |
| Manufacturer Street | 9450 SOUTH STATE STREET |
| Manufacturer City | SANDY UT 84070 |
| Manufacturer Country | US |
| Manufacturer Postal | 84070 |
| Manufacturer Phone | 8015652341 |
| Manufacturer G1 | BECTON DICKINSON MEDICAL SYSTEMS |
| Manufacturer Street | ROUTE 7 AND GRACE WAY |
| Manufacturer City | CANAAN CT 06018 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 06018 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SYRINGE ORAL 10ML CLEAR |
| Generic Name | LIQUID MEDICATION DISPENSER |
| Product Code | KYW |
| Date Received | 2019-02-27 |
| Catalog Number | 305219 |
| Lot Number | UNKNOWN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECTON DICKINSON MEDICAL SYSTEMS |
| Manufacturer Address | ROUTE 7 AND GRACE WAY CANAAN CT 06018 US 06018 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-02-27 |