MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2015-11-04 for CRYO TIP 40709 manufactured by Irvine Scientific Sales Co., Inc..
[31013000]
On (b)(6) 2015, the irvine scientific, quality and technical support scientist was informed by our irvine scientific territory manager that he had visited a customer, the scientific directory at a fertility center and that they had a few cases of cryo tips exploding when they transferred them into a waterbath to thaw (warm) them. These events occurred as follows: cryo tip lot #40709 t094 (manufacture date: january 14, 2015, expiration date: february 4, 2017) thawed on (b)(6), 2015. Cryo tip lot #40709 t071a (manufacture date: august 2, 2012, expiration date: september 14, 2014) thawed on (b)(6), 2015. Cryo tip lot #40709 t073a (manufacture date: june 19, 2012, expiration date: november 26, 2014) thawed on (b)(6), 2014. On (b)(6), 2015, the irvine scientific technical application specialist (tas) spoke to the customer to review the events that were reported. The tas reviewed the loading and sealing of the specimens in the cryo tip. The tas offered to visit the customer to review their sealing procedure and it was declined by the customer. As a result irvine scientific is filing this mdr with an abundance of caution. This mdr submission is our initial and final report. A f/u report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[31013001]
On (b)(6), 2015, the irvine scientific, quality and technical support scientist was informed by our irvine scientific territory manager that he had visited a customer, the scientific directory at a fertility center and that they had a few cases of cryo tips exploding when they transferred them into a waterbath to thaw (warm).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2022379-2015-00001 |
| MDR Report Key | 5207151 |
| Report Source | OTHER |
| Date Received | 2015-11-04 |
| Date of Report | 2015-11-04 |
| Date of Event | 2015-10-05 |
| Date Mfgr Received | 2015-10-05 |
| Device Manufacturer Date | 2015-01-14 |
| Date Added to Maude | 2015-11-06 |
| 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 | MS. JAYME YAMAGUCHI-OWENS |
| Manufacturer Street | 2511 DAIMLER ST |
| Manufacturer City | SANTA ANA CA 927055533 |
| Manufacturer Country | US |
| Manufacturer Postal | 927055533 |
| Manufacturer Phone | 9492617800 |
| Manufacturer G1 | IRVINE SCIENTIFIC SALES CO., INC. |
| Manufacturer Street | 2511 DAIMLER ST |
| Manufacturer City | SANTA ANA CA 927055533 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 927055533 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CRYO TIP |
| Generic Name | CRYO TIP |
| Product Code | MQH |
| Date Received | 2015-11-04 |
| Catalog Number | 40709 |
| Lot Number | 40709 T094 |
| Device Expiration Date | 2017-02-04 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | IRVINE SCIENTIFIC SALES CO., INC. |
| Manufacturer Address | 2511 DAIMLER ST SANTA ANA CA 927055533 US 927055533 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-11-04 |