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 2020-03-16 for BD? BLUNT FILL NEEDLE 305180 manufactured by Bd Medical (bd West) Medical Surgical.
[186330570]
Investigation summary: 2 samples were received. They came in ziploc plastic bag with no packaging blister. They were visually inspected. No deformation or excess of epoxy was observed. No drip overs on the needle or on the plastic hub. The epoxy at the needle base measures 1/8? High, which is acceptable. One empty- opened packaging blister came together with the needle assemblies. Root cause was not verified. 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. 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: no deformation or excess of epoxy was observed. This is the 1st complaint for lot # 9226751 for this type of defect or symptom. There was no documentation for this type of defect during the entire production run of this batch. Root cause description: root cause was not verified. Rationale: capa not required at this time.
Patient Sequence No: 1, Text Type: N, H10
[186330571]
It was reported that excess epoxy was found inside the bd? Blunt fill needle cap before use. The following information was provided by the initial reporter: "customer called and stated that "the blunt fill needle when pulled out of the protector cover , there was excess gum/glue that holds the needle and the hub inside the cap. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1911916-2020-00254 |
| MDR Report Key | 9836866 |
| Report Source | OTHER,USER FACILITY |
| Date Received | 2020-03-16 |
| Date of Report | 2020-03-10 |
| Date of Event | 2020-02-27 |
| Date Mfgr Received | 2020-03-05 |
| Device Manufacturer Date | 2019-08-14 |
| Date Added to Maude | 2020-03-16 |
| 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? BLUNT FILL NEEDLE |
| Generic Name | MANUAL SURGICAL INSTRUMENT FOR GENERAL USE |
| Product Code | GAA |
| Date Received | 2020-03-16 |
| Returned To Mfg | 2020-03-11 |
| Model Number | 305180 |
| Catalog Number | 305180 |
| Lot Number | 9226751 |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2020-03-16 |