MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-07-10 for BD BACTEC PLUS AEROBIC/F MEDIUM 442192 manufactured by Becton, Dickinson Caribe Ltd..
[3656491]
Customer was removing a bactec bottle from the instrument when it shattered in the tech's hand. Customer believes the bottle came to the lab broken but the crack was concealed by the label. The tech who removed the bottle was injured and received treatment from the occupational health nurse. The tech had a puncture wound that was cleaned and bandaged. The wound did not require stitches and the tech did not receive a tetanus shot. The tech did receive a hep b booster and blood work was drawn for hep b booster and blood work was drawn for hep b and rapid hiv testing. Additional testing will be done in 1 week for repeat rapid hiv and hep c. The broken bottle specimen was gram stained and provided negative results. The remaining anaerobic bottle from this pt in the instrument was negative at time of report.
Patient Sequence No: 1, Text Type: D, B5
[11040576]
No returned samples were received from the customer. Retention samples were visually inspected for any broken and/or cracked vials and all results were satisfactory. Batch history records were reviewed and results were satisfactory. The bd bactec plus aerobic/f and plus anaerobic/f media package insert states "prior to use, the user should examine the vials for evidence of damage or deterioration. Vials displaying turbidity, contamination, or discoloration (darkening) should not be used. On rare occasions, the glass bottle neck may be cracked and the neck may break during removal of the flip-off cap or in handling. Also, on rare occasions a vial may not be sealed sufficiently. In both cases the contents of the vials may leak or spill, especially if the vial is inverted. If the vial has been inoculated, treat the leak or spill with caution, as pathogenic organisms/agents may be present". Complaint trending was performed. There is no trend on this type of defect noted. No further action will be taken at this time. Bd will continue to trend on this type of event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1119779-2013-00007 |
| MDR Report Key | 3232289 |
| Report Source | 05 |
| Date Received | 2013-07-10 |
| Date of Report | 2013-06-26 |
| Date of Event | 2013-06-26 |
| Date Mfgr Received | 2013-06-26 |
| Device Manufacturer Date | 2013-04-05 |
| Date Added to Maude | 2013-07-18 |
| 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 | CHARLOTTE DANNENFELSER |
| Manufacturer Street | 7 LOVETON CIR. |
| Manufacturer City | SPARKS MD 21152 |
| Manufacturer Country | US |
| Manufacturer Postal | 21152 |
| Manufacturer Phone | 4103164367 |
| Manufacturer G1 | BECTON, DICKINSON CARIBE LTD. |
| Manufacturer Street | VICKS DRIVE 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 | BD BACTEC PLUS AEROBIC/F MEDIUM |
| Product Code | JTA |
| Date Received | 2013-07-10 |
| Catalog Number | 442192 |
| Lot Number | 3081053 |
| Device Expiration Date | 2014-01-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECTON, DICKINSON CARIBE LTD. |
| Manufacturer Address | CAYEY PR US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-07-10 |