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 3 ML BD LUER-LOK? LUER-LOK? TIP 309657 manufactured by Becton Dickinson.
[186696792]
Unknown manufacturer: there are multiple bd locations where this bd device may have been manufactured. A lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured. Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number. Medical device lot #: m361787 was provided, however, that is not a lot# for this product. Medical device expiration date: unknown. Pma / 510(k)#: k980987 ((b)(4)) k151766 ((b)(4)). 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. No root cause can be determined as no samples were received. The lot number is unknown, therefore device history record review (dhr) or quality notification review (qn) could not be performed. 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.
Patient Sequence No: 1, Text Type: N, H10
[186696793]
It was reported that leakage occurs from hub with a 3 ml bd luer-lok? Luer-lok? Tip. This occurred on 2 separate occasions during use, however, the patient information is unknown. The following information was provided by the initial reporter: it was reported that the customer experienced leaking form the connection between the needle and the syringe.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2243072-2020-00458 |
| MDR Report Key | 9862649 |
| Report Source | DISTRIBUTOR,OTHER |
| Date Received | 2020-03-20 |
| Date of Report | 2020-03-17 |
| Date of Event | 2020-02-14 |
| 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 | BECTON DICKINSON |
| Manufacturer Street | 1 BECTON DRIVE |
| Manufacturer City | FRANKLIN LAKES NJ 07417 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 07417 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 3 ML BD LUER-LOK? LUER-LOK? TIP |
| Generic Name | PISTON SYRINGE |
| Product Code | FMF |
| Date Received | 2020-03-20 |
| Model Number | 309657 |
| Catalog Number | 309657 |
| Lot Number | SEE H.10 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECTON DICKINSON |
| Manufacturer Address | 1 BECTON DRIVE FRANKLIN LAKES NJ 07417 US 07417 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-20 |