MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,other,user facility report with the FDA on 2020-02-04 for NEEDLE SPINAL S/SU 18GA 6IN QUINCKE 408360 manufactured by Bd Caribe Ltd..
[179110803]
There were multiple lot numbers reported to be involved. The information for each lot number is as follows: medical device lot #: 8123805, medical device expiration date: 2023-05-31, device manufacture date: 2018-07-02. Medical device lot #: 9088609, medical device expiration date: 2024-03-31, device manufacture date: 2019-05-29. Pma/510(k)#: preamendment. A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed.
Patient Sequence No: 1, Text Type: N, H10
[179110804]
It was reported that an unspecified number of needle spinal s/su 18ga 6in quincke experienced product damage/deformation -device still operable, and were involved in a serious injury in the form of medical intervention. During treatment, a portion of the device became embedded within the patient's kidney and had to be removed by a health care professional. No additional information regarding the outcome of this medical intervention has been specified. The following information was provided by the initial reporter: the device in question is: aig pl 150mm 18g 408360, ref: 408360 and number of series: 8123805 and 9088609. The problem encountered is: "during an nlpc (nephrolithotomy per cutaneous) use of the spinal needle to locate the kidney. Smaller needle diameter at the end of the needle impeding the passage of the guide that "spins" and can't remove the guide. " clinical consequences: "rupture of part of the guide wire in the patient's kidney. This part had to be recovered. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2618282-2020-00004 |
| MDR Report Key | 9667274 |
| Report Source | FOREIGN,OTHER,USER FACILITY |
| Date Received | 2020-02-04 |
| Date of Report | 2020-03-19 |
| Date of Event | 2019-12-18 |
| Date Mfgr Received | 2020-01-15 |
| Date Added to Maude | 2020-02-04 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | BDX BRETT WILKO |
| Manufacturer Street | 9450 SOUTH STATE STREET |
| Manufacturer City | SANDY UT 84070 |
| Manufacturer Country | US |
| Manufacturer Postal | 84070 |
| Manufacturer Phone | 8015652341 |
| Manufacturer G1 | BD CARIBE LTD. |
| Manufacturer Street | ROAD 31 K.M. 24.3 |
| Manufacturer City | JUNCOS |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEEDLE SPINAL S/SU 18GA 6IN QUINCKE |
| Generic Name | ANESTHESIA CONDUCTION NEEDLE |
| Product Code | BSP |
| Date Received | 2020-02-04 |
| Model Number | 408360 |
| Catalog Number | 408360 |
| Lot Number | SEE H.10 |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BD CARIBE LTD. |
| Manufacturer Address | ROAD 31 K.M. 24.3 JUNCOS US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-04 |