MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,other report with the FDA on 2020-03-20 for BD PRECISIONGLIDE? NEEDLE 305110 manufactured by Bd Medical (bd West) Medical Surgical.
[186320336]
Medical device expiration date: unknown. Device manufacture date: unknown. Investigation summary: no sample were received. Since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident. No root cause can? T be determined as no samples were received. Examination of the product involved may provide clarification as to the cause for the reported failure. 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. Based on no sample, the investigation concluded, bd was not able to verify the indicated failure. A device history review could not be completed as no batch number was provided.
Patient Sequence No: 1, Text Type: N, H10
[186320337]
It was reported that when drawing up insulin foreign matter was discovered in syringe with a bd precisionglide? Needle. This occurred on 3 separate occasions during use. The following information was provided by the initial reporter: (1 of 2 complaints) it was reported that the customer, when filling up the syringe with insulin, they noticed something floating around in the syringe.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1911916-2020-00284 |
| MDR Report Key | 9862720 |
| Report Source | DISTRIBUTOR,OTHER |
| Date Received | 2020-03-20 |
| Date of Report | 2020-03-17 |
| Date of Event | 2020-02-13 |
| Date Mfgr Received | 2020-03-13 |
| Date Added to Maude | 2020-03-20 |
| 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 PRECISIONGLIDE? NEEDLE |
| Generic Name | HYPODERMIC SINGLE LUMEN NEEDLE |
| Product Code | FMI |
| Date Received | 2020-03-20 |
| Model Number | 305110 |
| Catalog Number | 305110 |
| Lot Number | UNKNOWN |
| Operator | LAY USER/PATIENT |
| 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 | 2020-03-20 |