MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other,user facility report with the FDA on 2020-03-25 for BD INSYTE? AUTOGUARD? BC SHIELDED IV CATHETER 382634 manufactured by Becton Dickinson Infusion Therapy Systems Inc..
[188326853]
A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed.
Patient Sequence No: 1, Text Type: N, H10
[188326854]
It was reported that bd insyte? Autoguard? Bc shielded iv catheter was pierced by needle and caused hematoma. This was discovered during use. The following information was provided by the initial reporter: material no. : 382634, batch no. : 9337157. It was reported that the needle pierced the catheter shaft causing hematoma and difficulty advancing. Per email: please see the product incident below, photos of the catheter are attached as well. The sample is available to be returned for analysis. Description of complaint: she stated that she did "flick" the catheter up, twisted, and brought it back down. When she went to insert catheter a large hematoma formed and then there was bleeding at the insertion site and she was also unable to advance catheter so she stopped, pulled back and noted the cath tip.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1710034-2020-00209 |
| MDR Report Key | 9879923 |
| Report Source | OTHER,USER FACILITY |
| Date Received | 2020-03-25 |
| Date of Report | 2020-03-09 |
| Date of Event | 2020-03-05 |
| Date Mfgr Received | 2020-03-05 |
| Device Manufacturer Date | 2019-12-03 |
| Date Added to Maude | 2020-03-25 |
| 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 | 8015652341 |
| 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 | 3 |
| Brand Name | BD INSYTE? AUTOGUARD? BC SHIELDED IV CATHETER |
| Generic Name | INTRAVASCULAR CATHETER |
| Product Code | FOZ |
| Date Received | 2020-03-25 |
| Model Number | 382634 |
| Catalog Number | 382634 |
| Lot Number | 9337157 |
| Device Availability | * |
| 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. Other | 2020-03-25 |