MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2010-06-10 for CAPIOX BUBBLE TRAPS XX*XH041 manufactured by Terumo Corp., Ashitaka.
[2747634]
The user facility reported that during set-up, the holder for the bubble trap broke. The product was changed out and the surgery was completed successfully.
Patient Sequence No: 1, Text Type: D, B5
[9818578]
The actual device was not returned to terumo for eval. A review of the dhr of the involved product code for the period of the past three years confirmed there were no indications of production related problems. A review of the complaint files confirmed that there have been no previous reports for this product code. With no lot number info, the mfg date of the actual device was untraceable. The exp of this product code is not established due to the product nature. The cause of this event cannot be determined due to the absence of the actual device and lot number. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9681834-2010-00044 |
| MDR Report Key | 2554399 |
| Report Source | 05,06 |
| Date Received | 2010-06-10 |
| Date of Report | 2010-05-17 |
| Date of Event | 2010-05-12 |
| Date Facility Aware | 2010-05-17 |
| Report Date | 2010-05-17 |
| Date Mfgr Received | 2010-05-17 |
| Date Added to Maude | 2012-05-02 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MICHAEL SILVESTRI, MGR |
| Manufacturer Street | 125 BLUE BALL RD. |
| Manufacturer City | ELKTON MD 21921 |
| Manufacturer Country | US |
| Manufacturer Postal | 21921 |
| Manufacturer Phone | 8002623304 |
| Manufacturer G1 | TERUMO CORP., ASHITAKA |
| Manufacturer Street | 150 MAIMAIGI-CHO |
| Manufacturer City | FUJINOMIYA, SHIZUOKA 418 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 418 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CAPIOX BUBBLE TRAPS |
| Generic Name | BUBBLE TRAP |
| Product Code | KRL |
| Date Received | 2010-06-10 |
| Model Number | NA |
| Catalog Number | XX*XH041 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TERUMO CORP., ASHITAKA |
| Manufacturer Address | 150 MAIMAIGI-CHO FUJINOMIYA, SHIZUOKA 418 JA 418 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-06-10 |