MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-03 for UNSPECIFIED BD? DEVICE UNKNOWN manufactured by Becton Dickinson.
[129319849]
Date of event: unknown. The date received by manufacturer has been used for this field. Medical device expiration date: unknown. (b)(6). Device manufacture date: unknown. 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. Investigation summary: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident. No root cause can be determined as no samples were received. Examination of the product involved may provide clarification as to the cause for the reported failure. We appreciate you taking the time to bring this observation to our attention. 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 trends. Based on no sample, the investigation concluded, bd was not able to verify the indicated failure. A device history review could not be completed as no batch number was provided. Root cause description: undetermined. Rationale: batch#/sample available. No further investigation required.
Patient Sequence No: 1, Text Type: N, H10
[129319850]
It was reported that unspecified bd? Device filter needle was defective. No serious injury or medical intervention was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2243072-2018-01733 |
| MDR Report Key | 8125191 |
| Date Received | 2018-12-03 |
| Date of Report | 2018-11-21 |
| Date of Event | 2018-11-16 |
| Date Mfgr Received | 2018-11-16 |
| Date Added to Maude | 2018-12-03 |
| 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 | 8015652845 |
| Manufacturer G1 | BECTON DICKINSON |
| Manufacturer Street | 1 BECTON DRIVE |
| Manufacturer City | FRANKLIN LAKES NJ 07417 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 07417 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | UNSPECIFIED BD? DEVICE |
| Generic Name | UNKNOWN |
| Product Code | FPB |
| Date Received | 2018-12-03 |
| Catalog Number | UNKNOWN |
| Lot Number | UNKNOWN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECTON DICKINSON |
| Manufacturer Address | 1 BECTON DRIVE FRANKLIN LAKES NJ 07417 US 07417 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-12-03 |