MAUDE Adverse Event Report: SAGE IN-VITRO FERTILIZATION INC. PURCEPTION 80 PERCENT LOWER PHASE GRANDIENT; PURECEPTION MEDIA

Catalog Number ART-2080

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Pain (1994); Toxicity (2333)

Event Date 07/15/2014

Event Type  Injury  

Event Description

"we have received complaint from the israeli health ministry that in one of our sperm laboratory unit, three women were insemination (iui) from sperm donations and almost immediately after injection (after half an hour) 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 seems to them that the cause is not a bacterial infection but rather atoxic response.".

Manufacturer Narrative

(b)(4).Conclusion: an assignable caused could not be determined as the products met all approved release specification 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 re-staging activities prior to procedure, the catheter used, or improper washing of the sperm samples (see fishbone diagram above).The retention samples of the subject lots tested show that the product 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.

• Brand Name: PURCEPTION 80 PERCENT LOWER PHASE GRANDIENT
• Type of Device: PURECEPTION MEDIA
• Manufacturer (Section D): SAGE IN-VITRO FERTILIZATION INC.; pasadena CA
• Manufacturer Contact: nana banafo ; 75 corporate dr; trumbull, CT 06611 ; 2036015200
• MDR Report Key: 4058347
• MDR Text Key: 4811584
• Report Number: 2031459-2014-00002
• Device Sequence Number: 1
• Product Code: MQL
• Combination Product (y/n): N
• Reporter Country Code: IS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/16/2015
• Device Catalogue Number: ART-2080
• Device Lot Number: D197 C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/15/2015
• Initial Date FDA Received: 08/06/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/16/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention