MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2005-06-23 for BACTEC PEDS PLUS/F 442194 manufactured by Bd Caribe, Ltd..
[21470042]
Further investigation into this event indicates that the blood specimen was likely drawn during the morning and the inoculated blood culture bottle was not placed into the bactec 9050 instrument until 1:00pm in the afternoon. In this instance, there must have been significant growth of the k. Pneumoniae from the time the blood was inoculated into the vial and its receipt into the laboratory, since there were enough organisms for the direct gram stain to be positive, as well as enough for a direct id/ast procedure (both of which would require approximately 100,000 orgs/ml). The most likely reason that the instrument failed to detect this organism would be the delayed entry of the vial into the instrument, which gave the organism an opportunity for significant growth, prior to entry into the instrument. Patients with signs of suspected sepsis are empirically treated with broad-spectrum antibiotics. The recovery of the etiologic agent from a blood culture, as well as the subsequent identification and antimicrobial susceptibility results, are important in the management of the patient, in order to ensure that appropriate antibiotics are continued to be given to the patient. As noted in b. 5. The patient recovered from the sepsis event. Retention samples of the same lot of culture media were evaluated using the organism involved in this event with acceptable recovery. The batch history record for this lot was reviewed and found acceptable. Unable to confirm this event.
Patient Sequence No: 1, Text Type: N, H10
[21592376]
A septic premature infant had approximately 1 ml of blood inoculated into a bactec peds plus culture medium bottle. The bottle was subsequently loaded into a bactec 9050 instrument for blood culturing. The inoculated bottle remained instrument negative for 5 days of incubation. Direct microscopic examination and direct culture/susceptibility testing was performed from the specimen at the time the blood was inoculated into the blood culture bottle. An organism was isolated from the direct culture, klebsiella pneumoniae. The instrument negative blood culture bottle from this patient was examined microscopically and cultured. An organism was isolated from the instrument negative bottle, klebsiella pneumoniae. The premature infant recovered from the sepsis event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1119779-2005-00001 |
| MDR Report Key | 744593 |
| Report Source | 05 |
| Date Received | 2005-06-23 |
| Date of Report | 2005-06-21 |
| Date of Event | 2005-05-23 |
| Date Mfgr Received | 2005-05-23 |
| Date Added to Maude | 2006-08-08 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | JOHN GERLICH |
| Manufacturer Street | 7 LOVETON CIRCLE |
| Manufacturer City | SPARKS MD 21152 |
| Manufacturer Country | US |
| Manufacturer Postal | 21152 |
| Manufacturer Phone | 4103164464 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BACTEC PEDS PLUS/F |
| Generic Name | BLOOD CULTURE MEDIUM |
| Product Code | JTA |
| Date Received | 2005-06-23 |
| Model Number | NA |
| Catalog Number | 442194 |
| Lot Number | 4324535 |
| ID Number | NA |
| Device Expiration Date | 2005-09-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 732400 |
| Manufacturer | BD CARIBE, LTD. |
| Manufacturer Address | * CAYEY PR * US |
| Baseline Brand Name | BACTEC PEDS PLUS/F CULTURE MEDIUM |
| Baseline Generic Name | BLOOD CULTURE MEDIUM |
| Baseline Model No | NA |
| Baseline Catalog No | 442194 |
| Baseline ID | LOT# 4324535 |
| Baseline Shelf Life Contained | * |
| Baseline Shelf Life [Months] | 9 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K954927 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-06-23 |