MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,08 report with the FDA on 2014-08-06 for PURECEPTION 40 PERECENT UPPER PHASE GRADIENT ART-2040 manufactured by Sage In-vitro Fertilization Inc..
[4865863]
"we have received complaint from the (b)(6) that in one of our sperm laboratory unit, three women were insemination (iui) from sperm donations and almost immediately after injection (after half an our) developed intense pain in the lower abdomen and leukocytes from 14 to 18 thousand, the sperm donations were from different donors, there were no similar cases in the past, the injection was prepared by different employees and medical staff believes that due to the rapid development of symptoms it seemed to them that the cause is not a bacterial infection but rather atoxic response. "
Patient Sequence No: 1, Text Type: D, B5
[11920595]
(b)(4). Conclusion: an assignable cause could not be determined as the products met all approved release specifications at the time of manufacture before they were released. Based on review of all the information gathered during this investigation-associated sage documentation, manufacturing process, complaint history, and inspection of current inventory/retention sample , several external sources may have contributed to the reported complaint condition. Potential sources of product contamination include pre-stating activities prior to procedure, the catheter used , or improper washing of the sperm samples (see fish bone diagram above). The retention samples of the subject lots tested show that the products meets all approved release specifications. The customer did not return the actual samples involved. The product performs as intended. No further actions are needed at this time. The investigation may be reevaluated with any new additional information received.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2031459-2014-00001 |
| MDR Report Key | 4058344 |
| Report Source | 01,05,06,08 |
| Date Received | 2014-08-06 |
| Date of Report | 2014-07-15 |
| Date of Event | 2014-07-15 |
| Date Mfgr Received | 2015-07-15 |
| Device Manufacturer Date | 2013-07-24 |
| Date Added to Maude | 2014-09-08 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | NANA BANAFO |
| Manufacturer Street | 75 CORPORATE DR |
| Manufacturer City | TRUMBULL CT 06611 |
| Manufacturer Country | US |
| Manufacturer Postal | 06611 |
| Manufacturer Phone | 2036015200 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PURECEPTION 40 PERECENT UPPER PHASE GRADIENT |
| Generic Name | PUERCEPTION MEDIA |
| Product Code | MQL |
| Date Received | 2014-08-06 |
| Catalog Number | ART-2040 |
| Lot Number | D205 A |
| Device Expiration Date | 2015-07-24 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SAGE IN-VITRO FERTILIZATION INC. |
| Manufacturer Address | PASADENA CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-08-06 |