MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-17 for UNSPECIFIED BD? URINE COLLECTION DEVICE UNKNOWN manufactured by Becton Dickinson.
[130629551]
Date of event: unknown. The date received by manufacturer has been used for this field. 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. Device expiration date: unknown. Device manufacture date: unknown. 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
[130629552]
It was reported that a unspecified bd? Urine collection device had elevated rbc.
Patient Sequence No: 1, Text Type: D, B5
[134100757]
Investigation summary: bd had made multiple attempts to reach the customer in order to gather more information on the catalog and lot number; however, bd had not received a response from the customer. A good faith effort has been made and this complaint will be closed without further investigation at this time. If additional information is made available, this complaint will be reopened to assess the level of investigation needed. Bd technical support services had reached out to the customer for further troubleshooting. It was noted that the customer was concerned about the reporting of the results, but bd recommended that the rbc results of confirmatory microscopic be reported, since it was actually present as opposed to the particles detected by the analyzer. The customer indicated they have not received notification from siemens but the bd technician noted to the customer that bd had been in contact with siemens and that they (siemens) would be sending a notification shortly. Bd will continue to monitor this customer issue. Investigation conclusion: as no samples or photos were received for evaluation, the customer's indicated failure mode was not observed by bd. Root cause description: as there was no sample or photo available for evaluation, a root cause could not be determined. Rationale: complaints received for this device and reported condition will continue to be tracked and trended. Information will be captured on trend reports and monitored. The bd business team regularly reviews the collected data for identification of emerging trends.
Patient Sequence No: 1, Text Type: N, H10
[134100758]
It was reported that a unspecified bd? Urine collection device had elevated rbc.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2243072-2018-01826 |
| MDR Report Key | 8169821 |
| Date Received | 2018-12-17 |
| Date of Report | 2019-01-02 |
| Date of Event | 2018-11-30 |
| Date Mfgr Received | 2018-11-30 |
| Date Added to Maude | 2018-12-17 |
| 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? URINE COLLECTION DEVICE |
| Generic Name | COLLECTION DEVICE |
| Product Code | JTW |
| Date Received | 2018-12-17 |
| Catalog Number | UNKNOWN |
| Lot Number | UNKNOWN |
| Device Availability | * |
| Device Age | DA |
| 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 | 2018-12-17 |