MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07 report with the FDA on 2012-12-20 for ILLINOIS NEEDLE BONE MARROW 18G ADJ LEN DIN1518X manufactured by Carefusion.
[16910120]
(b)(6) appeared by ambulance to? (b)(6) hospital. The newborn had trouble in his/her? Left ventricle of the heart, and cyanosis was produced after? Severe ventricular fibrillation(vf).? One illinois bone marrow biopsy needle was placed in his/her left tibia, but leaked fluid was confirmed from? The hub part of the needle.? Other needle under? The same lot was placed in right tibia and secured an emergency vascular access, but? The patient was confirmed dead. On (b)(6) 2012, the following additional information was received from the international contact ((b)(6)):? Causal connection:? Unknown.? For the first biopsy needle a causal linkage between the leaked fluid and the patient death could not be confirmed.? Dr (b)(6) who? Performed the procedure, mentioned having no intention to make a connection between the patient death and the product defect. Cause of death: unknown.? Details were not confirmed.?? The distributor ((b)(4)) informed? The? International contact? That? The patient probably had? A cardiac arrest and was? Taken to the hospital. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
[16995588]
(b)(4). One sample was received for evaluation. A leak test was performed with a simulated tissue and no leak issues were identified. To perform the leak, a new syringe was utilized as the actual syringe used in the procedure was not received for evaluation. Therefore, the reported condition was not confirmed. A review of the internal manufacturing device history record for the lot reported did not identify any issues that may have contributed to the reported condition. During a review of the manufacturing process, no issues were identified that could relate personnel to the reported condition. The manufacturing and packaging processes are clearly defined. Regarding verification of the reported failure during quality inspection, the applicable procedure requires that several visual and functional tests be performed prior to releasing the product; however, no leak test is performed. The most probable root cause could not be determined as the sample received did not present issues during the leak test performed. The needle functioned as expected and the condition of the sample's material was noted to be in proper condition. Although the reported condition could not be confirmed and the probable root cause for this particular incident could not be determined, the manufacturing plant is continuing to monitor this issue for required corrective actions.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9680904-2012-00049 |
| MDR Report Key | 2882359 |
| Report Source | 01,05,07 |
| Date Received | 2012-12-20 |
| Date of Report | 2012-11-12 |
| Date of Event | 2012-11-12 |
| Date Mfgr Received | 2012-11-26 |
| Date Added to Maude | 2012-12-20 |
| 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 | JILL RITTORNO |
| Manufacturer Street | 1500 WAUKEGAN ROAD |
| Manufacturer City | MCGAW PARK IL 60085 |
| Manufacturer Country | US |
| Manufacturer Postal | 60085 |
| Manufacturer Phone | 8474737294 |
| Manufacturer G1 | CAREFUSION 203 LTD |
| Manufacturer Street | ZONA FRANCA LAS AMERICAS KM 22 E-1 |
| Manufacturer City | SANTO DOMINGO |
| Manufacturer Country | DR |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ILLINOIS NEEDLE BONE MARROW 18G ADJ LEN |
| Generic Name | TRAY, SURGICAL, NEEDLE |
| Product Code | FSH |
| Date Received | 2012-12-20 |
| Returned To Mfg | 2012-12-11 |
| Model Number | DIN1518X |
| Lot Number | D11030278 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION |
| Manufacturer Address | 1500 WAUKEGAN RD MCGAW PARK IL 60085 US 60085 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2012-12-20 |