MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06,07 report with the FDA on 2009-03-09 for BD INTERLINK 303369 manufactured by Becton Dickinson Infusion Therapy Systems.
[19957803]
When using the sample connected to lock syringe, the female of lever lock broke.
Patient Sequence No: 1, Text Type: D, B5
[20098347]
The sample was received on (b)(6) 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 | 2618282-2009-00003 |
| MDR Report Key | 1339374 |
| Report Source | 01,06,07 |
| Date Received | 2009-03-09 |
| Date of Report | 2009-02-12 |
| Date of Event | 2009-02-10 |
| Date Mfgr Received | 2009-02-12 |
| Date Added to Maude | 2010-09-29 |
| 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 | 2009-03-09 |
| Returned To Mfg | 2009-02-25 |
| Model Number | NA |
| Catalog Number | 303369 |
| Lot Number | UNK |
| ID Number | NA |
| 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 | 2009-03-09 |