MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2009-07-15 for BD INTERLINK 303369 manufactured by Becton Dickinson Infusion Therapy Systems.
[21783450]
A nurse was changing lines on a vasoactive infusion. She used a needleless access device used by the hospital. After making the change, the pt was noted to have a precipitous drop in blood pressure and heart rate. The nurse then noted that there was leaking at the site of the needleless access. Upon further investigation she found that the access device while appearing intact and screwing on to the needless port, was actually broken off and never made access to the needleless cap. Thus, the pt was not receiving any of the medication.
Patient Sequence No: 1, Text Type: D, B5
[21867587]
The sample was received on (b)(4) 2009 and is currently being decontaminated. Upon decontamination and completion of the investigation, a supplemental report will be submitted. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2618282-2009-00010 |
| MDR Report Key | 1416331 |
| Report Source | 00 |
| Date Received | 2009-07-15 |
| Date of Report | 2009-06-18 |
| Date of Event | 2009-05-14 |
| Date Mfgr Received | 2009-06-18 |
| Device Manufacturer Date | 2008-03-01 |
| Date Added to Maude | 2011-03-28 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | SALLY REAY |
| Manufacturer Street | 9450 SOUTH STATE STREET |
| Manufacturer City | SANDY UT 84070 |
| Manufacturer Country | US |
| Manufacturer Postal | 84070 |
| Manufacturer Phone | 8015652681 |
| Manufacturer G1 | BD CARIBE LTD. |
| Manufacturer Street | PO BOX 4010 |
| Manufacturer City | JUNCOS PR 00777401 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 00777 4010 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BD INTERLINK |
| Generic Name | THREADED LOCK CANNULA |
| Product Code | FGY |
| Date Received | 2009-07-15 |
| Returned To Mfg | 2009-07-14 |
| Model Number | NA |
| Catalog Number | 303369 |
| Lot Number | 8079651 |
| ID Number | NA |
| Device Expiration Date | 2010-04-30 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECTON DICKINSON INFUSION THERAPY SYSTEMS |
| Manufacturer Address | 9450 SOUTH STATE STREET SANDY UT 84070 US 84070 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2009-07-15 |