MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-09-26 for BACTEC PLUS AEROBIC/F CULTURE VIALS 442192 manufactured by Becton, Dickinson Caribe Ltd.
[3873282]
Customer contacted on (b)(6) 2013 to inform us of a bactec blood culture vial breaking. The customer had recently rec'd a broken bactec vial from their central receiving area. The customer utilizes a pneumatic tube system to transport some specimens to the lab. The vials are generally wrapped in an "eggshell type foam" before they are put into the pneumatic tube system. On (b)(6) 2013, a tech was removing one of the bactec blood culture vials from a plastic bag when it cut through their glove and also cut the technician's hand. The bactec blood culture vial contained a known positive hiv pt blood sample. The lab tech went to the emergency room / occupational health and received basic firs aid for the injury and placed on preventative medications due to the blood exposure. No further treatment info was available or provided by the tech or laboratory.
Patient Sequence No: 1, Text Type: D, B5
[11202862]
The utilization of a glass growth environment contributes to the performance of our bactec blood culture media. The durable glass bottle has a unique shape that contributes to the safety of the healthcare practitioner during specimen collection through utilization of our bd vacutainer blood collection products. In keeping with our focus on safety, we ask that a bactec bottle is always removed from the instrument in a direct horizontal motion without an upward or downward force. If a pneumatic tube system is utilized to transfer the bactec bottles from on location to another, the pneumatic tube holder (catalog # 445771) should be used to protect the bottles from potential impact. All of the bactec blood culture media have passed standard testing and release criteria. Bd bactec media are mfg in compliance with cgmp regulations and iso 9000 quality requirements. The sys and procedures involved in the mfr of bd bactec media are controlled from acquisition and approval of raw materials, through the mfg process, quality control testing and shipping of final product. Each product is prepared with approved components per approved master formula instructions. Equipment used in the mfg of bd bactec medial has been validated and is on a preventive maintenance schedule. The bd quality department visually inspected retention samples for any broken and/or cracked vials and obtained satisfactory results. A batch history review was also satisfactory and showed no evidence of the customers complaint. 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 | 1119779-2013-00010 |
| MDR Report Key | 3390043 |
| Report Source | 05 |
| Date Received | 2013-09-26 |
| Date of Report | 2013-09-18 |
| Date of Event | 2013-09-02 |
| Date Mfgr Received | 2013-09-18 |
| Date Added to Maude | 2013-10-08 |
| 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 | BECTON, DICKINSON CARIBE LTD |
| Manufacturer Street | P. O. BOX 372860 |
| Manufacturer City | CAYEY PR 00737286 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 00737 2860 |
| 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 | 2013-09-26 |
| Catalog Number | 442192 |
| Lot Number | 3081128 |
| 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 00737286 US 00737 2860 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-09-26 |