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 2020-03-30 for INTIMA-II 24GAX0.75IN PRN SLM 383028 manufactured by Bd Rapis Diagnostics (suzhou) Co. Ltd..
[187102222]
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
[187102223]
It was reported that intima-ii 24gax0. 75in prn slm separated after placement. The following information was provided by the initial reporter: "(b)(6)year-old boy was injected with the needle on the back of right hand, after the treatment and going back home with the needle, the catheter was broken in the blood vessel of the body, the section of the tube was in half to two-thirds of the length of the fracture, so the boy was back to the hospital for treatment, at the night of 8 march , the child had scanned with ct , it was suspected in the small intestine, there is no discharge (according to the head nurse of hospital that was likely to be a child's bit, eventually reason was not sure) and unknown reason caused this fracture. At present, the patient's condition and mood were stable, and the hospital is relatively stable; photos could be provided when samples are returned without defects; no need of green claims; requested to issue a formal report and deal with it as soon as possible. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006948883-2020-00102 |
| MDR Report Key | 9898412 |
| Report Source | FOREIGN,OTHER,USER FACILITY |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-10 |
| Date of Event | 2020-03-08 |
| Date Mfgr Received | 2020-03-08 |
| Device Manufacturer Date | 2019-07-16 |
| Date Added to Maude | 2020-03-30 |
| 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 | BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. |
| Manufacturer Street | 9 RUI PU ROAD EXPORT ZONE B |
| Manufacturer City | SUZHOU |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INTIMA-II 24GAX0.75IN PRN SLM |
| Generic Name | CATHETER |
| Product Code | FOZ |
| Date Received | 2020-03-30 |
| Catalog Number | 383028 |
| Lot Number | 9197414 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. |
| Manufacturer Address | 9 RUI PU ROAD EXPORT ZONE B SUZHOU US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-30 |