MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-10-11 for RPR CARD TEST KIT NO. 110 275005 manufactured by Bd Caribe, Ltd..
[16102216]
A customer was opening the glass ampoule when it cracked, cutting the pad of his thumb. The tech washed the cut with soap and water. He visited the occupational health department where he received a bandaid for the affected area and a tetanus shot as a precaution.
Patient Sequence No: 1, Text Type: D, B5
[16338134]
No returns were received for testing from the customer. Three samples were tested for ampoule breakage. No anomalies were noted. Each ampoule contained a pre-installed ampule opener. The batch history record and ampoule incoming results were also reviewed with no discrepancies noted. Batch history review also noted that each ampoule had a disposable ampoule opener inserted into the packaging. Complaint data was reviewed and there are currently no trends for this type of issue. No corrective actions are warranted at this time. Bd will continue to monitor this type of issue.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1119779-2011-00005 |
| MDR Report Key | 2299335 |
| Report Source | 05 |
| Date Received | 2011-10-11 |
| Date of Report | 2011-09-13 |
| Date of Event | 2011-09-13 |
| Date Mfgr Received | 2011-09-13 |
| Device Manufacturer Date | 2011-03-01 |
| Date Added to Maude | 2011-10-19 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | CHARLOTTE DANNENFELSER |
| Manufacturer Street | 7 LOVETON CIR. |
| Manufacturer City | SPARKS MD 21152 |
| Manufacturer Country | US |
| Manufacturer Postal | 21152 |
| Manufacturer Phone | 4103164367 |
| Manufacturer G1 | BD CARIBE, LTD. |
| Manufacturer Street | VICKS DR. LOT #6 |
| Manufacturer City | CAYEY PR 00737 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 00737 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RPR CARD TEST KIT NO. 110 |
| Product Code | GMQ |
| Date Received | 2011-10-11 |
| Catalog Number | 275005 |
| Lot Number | 1059853 |
| Device Expiration Date | 2013-03-31 |
| Operator | HEALTH PROFESSIONAL |
| 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 | CAYEY PR US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-10-11 |