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 2020-03-23 for BD INSYTE? AUTOGUARD? BC SHIELDED IV CATHETER BLOOD CONTROL TECHNOLOGY 382544 manufactured by Becton Dickinson Infusion Therapy Systems Inc..
[188326746]
Medical device expiration date: unknown. Device manufacture date: unknown. 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
[188326747]
It was reported that bd insyte? Autoguard? Bc shielded iv catheter blood control technology 18ga 1. 16in (1. 3 x 30 mm) broke after placement the following information was provided by the initial reporter: "patient care technician was removing this patient's iv as he was being discharged. Upon removal, they observed that the tip of the iv was missing a small piece. The physician was called and ordered a ultrasound of the patient's arm to be done. There was no echogenic material seen in the vein but there was a nonocclusive mural thrombus. This iv was place on (b)(6) 2020. We do not know the lot number as the packaging was not saved, but on the dressing which we believe is the original dressing, has the numbers 334893 on the tape. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1710034-2020-00199 |
| MDR Report Key | 9869454 |
| Report Source | OTHER,USER FACILITY |
| Date Received | 2020-03-23 |
| Date of Report | 2020-03-03 |
| Date of Event | 2020-02-21 |
| Date Mfgr Received | 2020-03-02 |
| Date Added to Maude | 2020-03-23 |
| 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 BLOOD CONTROL TECHNOLOGY |
| Generic Name | INTRAVASCULAR CATHETER |
| Product Code | FOZ |
| Date Received | 2020-03-23 |
| Returned To Mfg | 2020-03-13 |
| Catalog Number | 382544 |
| Lot Number | UNKNOWN |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| 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 | 2020-03-23 |