MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-05 for BD VACUTAINER? K2 EDTA 5.4MG 367228 manufactured by Bd (suzhou).
[110586063]
Pma / 510(k) #: there is no 510(k) for this device as it is manufactured outside the us and not sold in the us. Investigation summary: bd received samples and photos from the customer facility for investigation. The photos were evaluated and the customer? S indicated failure mode for embedded fm with the incident lot was observed. Additionally, evaluation of the customer samples was performed and embedded fm was observed. A review of the manufacturing records was completed for the incident lot and no issues were identified. Conclusion: based on evaluation of the customer photos, the customer? S indicated failure mode for embedded fm with the incident lot was observed. Additionally, evaluation of the customer samples was conducted and embedded fm was observed. Root cause description: based on the investigation, a root cause could not be determined. Rationale: complaints received for this device and reported condition will continue to be tracked and trended. Information will be captured on trend reports and monitored. The bd business team regularly reviews the collected data for identification of emerging trends.
Patient Sequence No: 1, Text Type: N, H10
[110586064]
It was reported that bd vacutainer? K2 edta 5. 4mg tube was found with fm. No report of medical intervention or serious injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006948883-2018-00374 |
| MDR Report Key | 7568978 |
| Date Received | 2018-06-05 |
| Date of Report | 2018-05-09 |
| Date of Event | 2018-02-13 |
| Date Mfgr Received | 2018-02-13 |
| Device Manufacturer Date | 2017-07-31 |
| Date Added to Maude | 2018-06-05 |
| 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 |
| 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 | 8015652845 |
| Manufacturer G1 | BD (SUZHOU) |
| Manufacturer Street | NO. 5 BAIYU ROAD SUZHOU INDUSTRIAL PARK |
| Manufacturer City | SUZHOU |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BD VACUTAINER? K2 EDTA 5.4MG |
| Generic Name | BLOOD SPECIMEN COLLECTION DEVICE |
| Product Code | PJE |
| Date Received | 2018-06-05 |
| Returned To Mfg | 2018-02-25 |
| Catalog Number | 367228 |
| Lot Number | 7205404 |
| Device Expiration Date | 2018-10-31 |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BD (SUZHOU) |
| Manufacturer Address | NO. 5 BAIYU ROAD SUZHOU INDUSTRIAL PARK SUZHOU |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-06-05 |