|
|
| Catalog Number 2N3399 |
| Event Date 04/11/2001 |
|
Event Type
Malfunction
|
|
Event Description
|
Acct.
Reports that the septum "exploded" when the nurse went to flush the injection site.
States the injection site was attached directly to the iv catheter hub.
States they use the "lifeshield" blunt cannula to access the injection site.
No pt injury occurred.
|
| |
|
Manufacturer Narrative
|
Evaluation results: no sample has been received for evaluation.
If one does become available in the future, a followup report will be filed.
|
| |
|
Search Alerts/Recalls
|
|
|
| Brand Name | INTERLINK INJECTION SITE |
|---|
| Type of Device | INJECTION SITE |
|---|
| Baseline Brand Name | INTERLINK INJECTION SITE |
|---|
| Baseline Generic Name | INTERLINK INJECTION SITE |
|---|
| Baseline Catalogue Number | 2N3399 |
|---|
| Baseline Device Family | INTERLINK INJECTION SITES |
|---|
| Baseline Device 510(K) Number | K925126 |
|---|
| Baseline Device PMA Number | |
|---|
| Baseline Shelf Life Information |
No
|
|---|
| Baseline Preamendment? |
No
|
|---|
| Transitional? |
No
|
|---|
| 510(K) Exempt? |
No
|
|---|
| Shelf Life(Months) | NA |
|---|
| Date First Marketed | 03/08/1990 |
|---|
| Manufacturer (Section F) |
| BAXTER HEALTHCARE (SG) |
| 2 woodlands indust park d |
| singapore |
|
SINGAPORE
738750
|
|
| Manufacturer (Section D) |
| BAXTER HEALTHCARE (SG) |
| 2 woodlands indust park d |
| singapore |
|
SINGAPORE
738750
|
|
| Manufacturer Contact |
|
debbie
lahr
|
| route 120 & wilson road |
| round lake
, IL 60073 |
| (847)
270
-4695
|
|
| Device Event Key | 321149 |
|---|
| MDR Report Key | 331780 |
|---|
| Event Key | 312261 |
|---|
| Report Number | 6000001-2001-00208 |
|---|
| Device Sequence Number | 1 |
|---|
| Product Code | FOZ |
|---|
| Report Source |
Manufacturer
|
|---|
| Source Type |
Other
|
|---|
| Reporter Occupation |
Other
|
| Type of Report
| Initial |
|---|
| Report Date |
04/11/2001 |
| 1 Device Was Involved in the Event | |
| 1 Patient Was Involved in the Event | |
| Date FDA Received | 05/08/2001 |
|---|
| Is This An Adverse Event Report? |
No
|
|---|
| Is This A Product Problem Report? |
Yes
|
|---|
| Device Operator |
Health Professional
|
| Device Catalogue Number | 2N3399 |
|---|
| Device LOT Number | NA01 |
|---|
| Was Device Available For Evaluation? |
No
|
|---|
| Is The Reporter A Health Professional? |
No
|
|---|
| Was the Report Sent to FDA? |
No
|
|---|
| Date Manufacturer Received | 04/11/2001 |
|---|
| Was Device Evaluated By Manufacturer? |
No
|
|---|
| Is The Device Single Use? |
Yes
|
|---|
| Is the Device an Implant? |
No
|
|---|
| Is this an Explanted Device? |
|
|---|
| Type of Device Usage |
Unkown
|
|---|
|
|
Database last updated on January 30, 2009
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