MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,other,user facility report with the FDA on 2020-01-28 for BD ARTERIAL CANNULA 20G/1.10MM X 45MM 682245 manufactured by Becton Dickinson Medical (singapore).
[181964971]
Date of event: unknown. The date received by manufacturer has been used for this field. A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed. There were multiple lot numbers reported to be involved. The information for each lot number is as follows: medical device lot #: 6200099. Medical device expiration date: 2021-07-31. Device manufacture date: 2016-08-14. Medical device lot #: 8166188. Medical device expiration date: 2021-07-31. Device manufacture date: 2016-08-14. Medical device lot #: 8230349. Medical device expiration date: 2023-08-31. Device manufacture date: 2018-08-18. Medical device lot #: 7199168. Medical device expiration date: 2022-07-31. Device manufacture date: 2017-08-30.
Patient Sequence No: 1, Text Type: N, H10
[181964972]
It was reported that an unspecified number of bd arterial cannula 20g/1. 10mm x 45mm experienced a catheter that broke/separated from the hub during use. The following information was provided by the initial reporter: after changing the pressure bandage it was noted that a part of the arterial cannula remained in the artery. Possibly it broke during removal of the cannula, which is why the artery could not close.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8041187-2020-00023 |
| MDR Report Key | 9639814 |
| Report Source | FOREIGN,OTHER,USER FACILITY |
| Date Received | 2020-01-28 |
| Date of Report | 2020-02-18 |
| Date of Event | 2020-01-08 |
| Date Mfgr Received | 2020-01-08 |
| Date Added to Maude | 2020-01-28 |
| 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 |
| 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 MEDICAL (SINGAPORE) |
| Manufacturer Street | 30 TUAS AVENUE 2 |
| Manufacturer City | SINGAPORE |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BD ARTERIAL CANNULA 20G/1.10MM X 45MM |
| Generic Name | ARTERIAL CANNULA |
| Product Code | NDP |
| Date Received | 2020-01-28 |
| Catalog Number | 682245 |
| Lot Number | SEE H.10 |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECTON DICKINSON MEDICAL (SINGAPORE) |
| Manufacturer Address | 30 TUAS AVENUE 2 SINGAPORE |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-01-28 |