MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,other,user facility report with the FDA on 2020-03-19 for BD LUER-LOK? TIP SYRINGE 309653 manufactured by Bd Medical (bd West) Medical Surgical.
[186324281]
Date of event: unknown. The date received by manufacturer has been used for this field. Medical device expiration date: unknown. Device manufacture date: unknown. Investigation summary: two samples were received they came wrapped in a piece of paper. One has 45ml of a solution with a tip cap; the other one is empty. Both were visually inspected first with naked eye and after with a microscope; no foreign matter was observed. 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 review could not be completed as no batch number was provided. Investigation conclusion: no defects or damages were observed. Lot# is unknown. A complaint history check was not performed as the lot number is "unknown" for this complaint. Root cause description: root cause could not be determined. Rationale: capa not required at this time.
Patient Sequence No: 1, Text Type: N, H10
[186324282]
It was reported that 2 bd luer-lok? Tip syringes were found with floating foreign matter in them before use, with a"film" in the back of the plunger, and a small piece of "plastic" in the barrel. The following information was provided by the initial reporter: "we are having issues with our bd leur lock syringes. Several in the last two weeks (maybe more) have been found to have 'things' floating. They have been discovered in the pharmacy, a few were discarded without reporting, but they finally notified me last week. Last week it appeared to be a small piece of? Maybe plastic, this was a 20ml. I have three that i am currently looking at, one has a plunger that has particles of something that has migrated into the barrel of the syringe this is a 10ml, one has a film on the black part of the plunger, this is a 60ml, and one more 60ml that appears to be another small piece of plastic. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1911916-2020-00278 |
| MDR Report Key | 9857153 |
| Report Source | FOREIGN,OTHER,USER FACILITY |
| Date Received | 2020-03-19 |
| Date of Report | 2020-03-13 |
| Date of Event | 2020-03-12 |
| Date Mfgr Received | 2020-03-12 |
| Date Added to Maude | 2020-03-19 |
| 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 | 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 LUER-LOK? TIP SYRINGE |
| Generic Name | PISTON SYRINGE |
| Product Code | FMF |
| Date Received | 2020-03-19 |
| Returned To Mfg | 2020-03-16 |
| Model Number | 309653 |
| Catalog Number | 309653 |
| Lot Number | UNKNOWN |
| 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 | 2020-03-19 |