MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other,user facility report with the FDA on 2020-02-06 for BD NEEDLE SPINAL S/SU 25GA 3-1/2IN QUINCKE 405180 manufactured by Bd Caribe Ltd..
[179110889]
Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured. A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured. Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number. Medical device expiration date: unknown. Device manufacture date: unknown. Investigation summary: bd was unable to perform a thorough investigation as no sample, lot, or batch number were provided. Complaints received for this device and reported condition will continue to be tracked and trended. Information will be captured on trend reports and monitored monthly. Our business team regularly reviews the collected data for identification of emerging trend investigation conclusion: bd was not able to duplicate or confirm the customer? S indicated failure as no sample, batch, or lot code was provided. Root cause description: root cause is undetermined. Rationale: no sample, lot, or batch provided.
Patient Sequence No: 1, Text Type: N, H10
[179110890]
It was reported that while using the bd needle spinal s/su 25ga 3-1/2in quincke the healthcare provider received a contaminated needle stick. Verbatim: it was reported that a needle stick injury occurred on the clinician after having used the needle on the patient. In this occurrence the clinician recapped the needle after using it, then went to use it again and the needle recoiled and stuck the tech. In this needle stick occurrence, clinician used the needle on the patient, recapped it and were going to use it again when the needle 'recoiled' and stuck the tech.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2618282-2020-00005 |
| MDR Report Key | 9676627 |
| Report Source | OTHER,USER FACILITY |
| Date Received | 2020-02-06 |
| Date of Report | 2020-02-03 |
| Date of Event | 2020-01-29 |
| Date Mfgr Received | 2020-01-29 |
| Date Added to Maude | 2020-02-06 |
| 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 | BD NEEDLE SPINAL S/SU 25GA 3-1/2IN QUINCKE |
| Generic Name | SPINAL NEEDLE |
| Product Code | BSP |
| Date Received | 2020-02-06 |
| Model Number | 405180 |
| Catalog Number | 405180 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| 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 | 2020-02-06 |