MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,other,use report with the FDA on 2018-11-16 for ALARIS EXTENSION SET 20127E manufactured by Carefusion.
[128277373]
No product will be returned per customer. The customer complaint could not be confirmed because the product was discarded and not returned for failure investigation. The root cause of this failure was not identified.
Patient Sequence No: 1, Text Type: N, H10
[128277374]
Received a copy of the customer's medwatch from fda which states,? Intralipid syringe changed to current tubing infusing into uac(umbilical artery catheterization). Several hours after syringe changed, leakage noted on the floor with dripping noted around end of syringe and tubing. Tubing and syringe secured and removed from patient. Off pump tubing flushed with no occlusion noted but still dripping around tubing/syringe connection. New tubing obtain to test with no leaking noted. " an incomplete date of event of (b)(6) 2018 was provided. There was no patient harm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616066-2018-02239 |
| MDR Report Key | 8077802 |
| Report Source | HEALTH PROFESSIONAL,OTHER,USE |
| Date Received | 2018-11-16 |
| Date of Report | 2018-10-23 |
| Date Added to Maude | 2018-11-16 |
| 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 | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. ADE AJIBADE |
| Manufacturer Street | 10020 PACIFIC MESA BLVD |
| Manufacturer City | SAN DIEGO CA 921214386 |
| Manufacturer Country | US |
| Manufacturer Postal | 921214386 |
| Manufacturer Phone | 8586172000 |
| Manufacturer G1 | CAREFUSION |
| Manufacturer Street | 10020 PACIFIC MESA BLVD |
| Manufacturer City | SAN DIEGO CA 921214386 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 921214386 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ALARIS EXTENSION SET |
| Generic Name | SET, EXTENSION, INTRAVASCULAR |
| Product Code | FPB |
| Date Received | 2018-11-16 |
| Model Number | 20127E |
| Catalog Number | 20127E |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION |
| Manufacturer Address | 10020 PACIFIC MESA BLVD SAN DIEGO CA 921214386 US 921214386 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-11-16 |