MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,other report with the FDA on 2020-02-19 for BD SYRINGE INTEGRA 3ML W/NDL 23X1 RB 305271 manufactured by Becton Dickinson Medical Systems.
[184160764]
Date of event: unknown. The date received by manufacturer has been used for this field. Medical device expiration date: unknown. The state is not reported, therefore nj has been used. If additional information is reported this mdr will be updated with a supplemental report. 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.. A device history record review could not be performed as lot number was unknown. Complaints received for this device and reported condition will continue to be tracked and trended. Information will be captured on trend reports and monitored monthly. Our business team regularly reviews the collected data for identification of emerging trends. Investigation conclusion: unconfirmed: bd was not able to duplicate or confirm the customer? S indicated failure. Root cause description: no root cause can be determined. Rationale: no capa is required.
Patient Sequence No: 1, Text Type: N, H10
[184160767]
It was reported bd syringe integra 3ml w/ndl 23x1 rb retracted prematurely during use. The following information was provided by the initial reporter: verbatim: material no: 305271 batch no: unknown. It was reported that the needle retracted prematurely. Verbatim: caller states he injected a patient's knee with the syringe, 305271 and then the needle "disappeared". Where does the needle go? Caller states this was very "unsettling" and therefore he had an x-ray performed on the patient's knee to make sure it did not go into the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1213809-2020-00121 |
| MDR Report Key | 9729675 |
| Report Source | HEALTH PROFESSIONAL,OTHER |
| Date Received | 2020-02-19 |
| Date of Report | 2020-02-10 |
| Date of Event | 2020-02-05 |
| Date Mfgr Received | 2020-02-05 |
| Date Added to Maude | 2020-02-19 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 3 |
| Brand Name | BD SYRINGE INTEGRA 3ML W/NDL 23X1 RB |
| Generic Name | PISTON SYRINGE |
| Product Code | MEG |
| Date Received | 2020-02-19 |
| Catalog Number | 305271 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| 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 | 2020-02-19 |