MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-07 for UNSPECIFIED BD? LUER LOCK 381434 manufactured by Becton Dickinson Infusion Therapy Systems Inc..
[116867769]
Date of event: unknown. Medical device expiration date: unknown. A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed. 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.
Patient Sequence No: 1, Text Type: N, H10
[116867810]
It was reported that an unspecified bd? Luer lock product are pulling apart at the connection. There was no report of exposure, serious injury or medical intervention.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2243072-2018-01036 |
| MDR Report Key | 7758136 |
| Date Received | 2018-08-07 |
| Date of Report | 2018-11-19 |
| Date of Event | 2018-07-16 |
| Date Mfgr Received | 2018-07-18 |
| Date Added to Maude | 2018-08-07 |
| 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 | 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 INFUSION THERAPY SYSTEMS INC. |
| Manufacturer Street | 9450 SOUTH STATE STREET |
| Manufacturer City | SANDY UT 84070 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 84070 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | UNSPECIFIED BD? LUER LOCK |
| Generic Name | UNSPECIFIED BD? LUER LOCK |
| Product Code | KST |
| Date Received | 2018-08-07 |
| Catalog Number | 381434 |
| 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 INFUSION THERAPY SYSTEMS INC. |
| Manufacturer Address | 9450 SOUTH STATE STREET SANDY UT 84070 US 84070 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Other | 2018-08-07 |