MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-13 for TEMNO NEEDLE BIOPSY 18GX15CM ADJ COAXIAL ACT1815 manufactured by Carefusion, Inc.
[72784563]
(b)(4). A follow up submission will be done upon completion of carefusions investigation or if additional information becomes available. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[72784564]
Customer reported; smaller needle did not fit down larger needle to obtain bx. After numerous attempts the patient began to develop a pneumothorax and the radiologist stopped procedure without being able to collect a sample. Patient was hospitalized due to procedure.
Patient Sequence No: 1, Text Type: D, B5
[78600048]
(b)(4). One (1) sample from lot #0001022711 was provided for evaluation. During visual analysis it was identified there was a clear dot of what appeared to be adhesive within a couple inches of one side of the tip of the cannula. The adhesive dot was large enough to prevent the temno needle from going down the associated coaxial needle. Therefore, failure mode could be confirmed. A review of the internal manufacturing device record and raw material history files for the reported lot number was performed and no recorded quality problems or rejections related to this incident were found. It was confirmed that procedural and functional requirements needed for its release were met. Lot #0001022711 was manufactured on 25-nov-2016. Definitive root cause could not be determined. Most probable root cause could be related to adhesive not being properly dispensed due to process/ method not defined or followed appropriately. This failure mode will be entered into the complaint tracking system and tracked & trended for future occurrences of any similar failure modes.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9680904-2017-00106 |
| MDR Report Key | 6492297 |
| Date Received | 2017-04-13 |
| Date of Report | 2017-06-08 |
| Date of Event | 2017-03-23 |
| Date Mfgr Received | 2017-03-29 |
| Date Added to Maude | 2017-04-13 |
| 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 | 3 |
| Manufacturer Contact | ANNA WEHRHEIM |
| Manufacturer Street | 75 NORTH FAIRWAY DRIVE |
| Manufacturer City | VERNON HILLS IL 60061 |
| Manufacturer Country | US |
| Manufacturer Postal | 60061 |
| Manufacturer G1 | CAREFUSION, INC |
| Manufacturer Street | ZONA FRANCA LAS AMERICAS |
| Manufacturer City | SANTO DOMINGO |
| Manufacturer Country | DR |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TEMNO NEEDLE BIOPSY 18GX15CM ADJ COAXIAL |
| Generic Name | GUIDE, NEEDLE, SURGICAL |
| Product Code | GDF |
| Date Received | 2017-04-13 |
| Model Number | ACT1815 |
| Lot Number | 0001022711 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION, INC |
| Manufacturer Address | 75 NORTH FAIRWAY DRIVE VERNON HILLS IL 60061 US 60061 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2017-04-13 |