MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-01-08 for BACTEC PLUS AEROBIC/F CULTURE VIALS 442192 manufactured by Becton, Dickinson & Co..
[4163106]
Customer reported that they have had a number of bactec bottles that have broken in their pneumatic tube system, and a couple that have broken when dropped in their lab. They have also had a few bottles that have had large chips broken off of them and bottles that have cracked, but are not leaking. These bottles have incubated in an incubator rather than put into the bactec instrument. Customer is currently working on plastic bottle study. Customer stated a triage employee was removing bactec bottles from pneumatic tube system and upon setting up samples for delivery to the lab the employee cut their hand. Because the incident occurred some time ago she is unsure of the exact details of the incident. She is unsure if the employee was wearing ppe. Typically bottles are wrapped in bubble wrap with a sponge material. In this particular case, they are uncertain if the sponge material was used. The injured employee was treated immediately with azt due to the patient being infected with hiv. They are unsure of how long the employee was treated with azt or any follow up care. Going forward, they will report all broken bottles and injuries to bd immediately.
Patient Sequence No: 1, Text Type: D, B5
[11558703]
Customer called to report recent issues they had with broken bottles and alerted technical services to this event more than 2 years ago. Technical service documented the complaint with the limited info the customer could provide. No returned samples were received from the customer. Customer was unable to provide a lot number for review of retention samples. Qa is unable to perform an investigation since no lot number, returned product, or photos were available from the customer. Bd will continue to monitor and trend on this type of event. 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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1119779-2014-00002 |
| MDR Report Key | 3581484 |
| Report Source | 05 |
| Date Received | 2014-01-08 |
| Date of Report | 2013-12-24 |
| Date of Event | 2011-09-19 |
| Date Mfgr Received | 2013-12-24 |
| Date Added to Maude | 2014-01-22 |
| 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 211520999 |
| Manufacturer Country | US |
| Manufacturer Postal | 211520999 |
| Manufacturer Phone | 4103164367 |
| Manufacturer G1 | BECTON, DICKINSON & CO. |
| Manufacturer Street | 7 LOVETON CIR. |
| Manufacturer City | SPARKS MD 21152099 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 21152 0999 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BACTEC PLUS AEROBIC/F CULTURE VIALS |
| Product Code | JTA |
| Date Received | 2014-01-08 |
| Catalog Number | 442192 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECTON, DICKINSON & CO. |
| Manufacturer Address | CAYEY PR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-01-08 |