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 2017-11-27 for BD MACRO-VUE? RPR CARD ANTIGEN SUSPENSION 270309 manufactured by Bd Caribe, Ltd.
[92969935]
Medical device expiration date: unknown. A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed. Device manufacture date: unknown.
Patient Sequence No: 1, Text Type: N, H10
[92969936]
It was reported that while using bd macro-vue? Rpr card antigen suspension, the antigen splashed in the eyes of the operator during use. Medical intervention required.
Patient Sequence No: 1, Text Type: D, B5
[109566053]
The customer complained of splash in their eyes. No laboratory test can be performed since lot number is unknown. The complaint history file for this product was verified and no other complaint were received with this customer claim. Safety data sheet was verified and it contains first aid measures for eye contact. ? After eye contact, rinse opened eye for 15 minutes under running water. Then consult your doctor?. Product insert has warning notice in case product be in contact with the eyes. Although lot number was not provided by customer, drop test of the last lot of needle received in house was verified. Satisfactory results were obtain when drop test was performed. The complaint was unconfirmed by bd service personnel. Root cause unknown, lot number was not provided by customer.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2647876-2017-00002 |
| MDR Report Key | 7060491 |
| Report Source | OTHER,USER FACILITY |
| Date Received | 2017-11-27 |
| Date of Report | 2017-12-01 |
| Date of Event | 2017-11-02 |
| Date Mfgr Received | 2017-11-02 |
| Date Added to Maude | 2017-11-27 |
| 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 CARIBE, LTD |
| Manufacturer Street | VICKS DRIVE LOT NO. 1 |
| Manufacturer City | CAYEY |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BD MACRO-VUE? RPR CARD ANTIGEN SUSPENSION |
| Generic Name | RPR ANTIGEN |
| Product Code | GMQ |
| Date Received | 2017-11-27 |
| Catalog Number | 270309 |
| Lot Number | UNKNOWN |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BD CARIBE, LTD |
| Manufacturer Address | VICKS DRIVE LOT NO. 1 CAYEY US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-11-27 |