MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other,user facility report with the FDA on 2020-02-07 for BD FLUNT FILL NEEDLE WITH FILTER 305211 manufactured by Bd Medical (bd West) Medical Surgical.
[179463180]
Investigation summary: no samples were received. Two photos were provided. They show a 1ml syringe and two needle assembly packaging blisters one is for a 30x? And other for 18x 1? Fill needle. A device history record review was completed with zero defects found. No quality notifications were written for this batch, nor for the associated assembly batches. Investigation conclusion: 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. Root cause description: root cause for the reported issue cannot be determined as samples would be needed for evaluation. Rationale: capa not required at this time.
Patient Sequence No: 1, Text Type: N, H10
[179463181]
It was reported that bd flunt fill needle with filter had foreign matter was found in the patients eye after injection. Inflammation occurred on 4 occasions during use and foreign matter occurred on 5 occasions during use. The following information was provided by the initial reporter: material no. : 305211, batch no. : 8173918. It was reported that silicone oil droplets and metallic flakes were observed in patients' eye after ocular injection which caused several cases of inflammation in the eye. Pr 3 of 3: this pr is for needle filter blunt fill 18x1-1/2. Per complaint: we are faced with a technical complaint where the doctor observed that after ocular injection silicone or silicon like droplets were present in the eye of the patient which claimed in 3 of 4 cases about eye inflammation. Additionally the doctor noticed "small metallic, irregularly shaped shimmering flakes floating in the anterior vitreous". They observed after ocular injection using the syringes and needles provided from bd , silicon oil droplets and metallic flakes in the eye of the patient. These observations were connected with an inflammation of the eyes of patients. Furthermore we were notified that it can be a general issue that silicone oil droplets are extracted from the syringe onto the product dosed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1911916-2020-00108 |
| MDR Report Key | 9682030 |
| Report Source | OTHER,USER FACILITY |
| Date Received | 2020-02-07 |
| Date of Report | 2020-01-31 |
| Date of Event | 2019-10-16 |
| Date Mfgr Received | 2020-01-30 |
| Device Manufacturer Date | 2018-06-22 |
| Date Added to Maude | 2020-02-07 |
| 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 | BD MEDICAL (BD WEST) MEDICAL SURGICAL |
| Manufacturer Street | 1852 10TH AVENUE |
| Manufacturer City | COLUMBUS NE 68601 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 68601 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BD FLUNT FILL NEEDLE WITH FILTER |
| Generic Name | MANUAL SURGICAL INSTRUMENT FOR GENERAL USE |
| Product Code | GAA |
| Date Received | 2020-02-07 |
| Model Number | 305211 |
| Catalog Number | 305211 |
| Lot Number | 8173918 |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BD MEDICAL (BD WEST) MEDICAL SURGICAL |
| Manufacturer Address | 1852 10TH AVENUE COLUMBUS NE 68601 US 68601 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-07 |