MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2007-07-23 for BD BBL SUB/VENTING UNITS FOR CULTURE BOTTLES 271056 manufactured by .
[671484]
A technician was removing sub/venting units from blood culture bottles. Someone called the technician's name and as the technician turned around, the tech stuck themself in the thumb with 2 vents. The vents were from 2 different pts as the tech was removing more that 1 vent at a time. Tech removed gloves and washed hands. Tech was then seen in the er and received a tetanus shot. Tech and pts are currently being tested for blood borne pathogens. Customer was unable to provide a lot number for the sub/venting units involved.
Patient Sequence No: 1, Text Type: D, B5
[7810898]
The bd bbl sub/venting units for culture bottles provide an open pathway for gas exchange as well as an easy method of subculturing. The product contains a blunt needle on one side and a beveled needle on the other end. The beveled edge pierces a septum cap while the blunt end is used to vent or subculture the culture bottle. The laboratory tech was utilizing unsafe practice in removing the sub/venting units from the blood culture vials. This incident resulted in the technician receiving a tetanus shot. No product malfunction of the device was reported by the customer. No further investigation can be conducted since the lot number is unk. This issue will continue to be monitored for trends.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1119779-2007-00007 |
| MDR Report Key | 884033 |
| Report Source | 05 |
| Date Received | 2007-07-23 |
| Date of Report | 2007-07-20 |
| Date of Event | 2007-07-02 |
| Date Mfgr Received | 2007-07-02 |
| Date Added to Maude | 2008-02-27 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | JOHN GERLICH |
| Manufacturer Street | 7 LOVETON CIR. |
| Manufacturer City | SPARKS MD 21152 |
| Manufacturer Country | US |
| Manufacturer Postal | 21152 |
| Manufacturer Phone | 4103164464 |
| Manufacturer G1 | REMEL |
| Manufacturer Street | 12076 SANTE FE DRIVE |
| Manufacturer City | LENEXA KS 66215 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 66215 |
| Single Use | 3 |
| Remedial Action | PM |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BD BBL SUB/VENTING UNITS FOR CULTURE BOTTLES |
| Generic Name | NA/LAB USE ONLY |
| Product Code | JSC |
| Date Received | 2007-07-23 |
| Catalog Number | 271056 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 948318 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-07-23 |