MAUDE Adverse Event Report: COOPERSURGICAL, INC. EZ-SQUEEZE & BULB 170

Model Number 7-72-3170/20

Device Problem Microbial Contamination of Device (2303)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/27/2021

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical, inc.Is currently investigating the condition reported.

Event Description

Multiple reports on tips & pipette submitted by csi (b)(4).Incident detail- they have had a lab infection.This is across multiple patients.They suspect that the most likely source is the gtl media from vl.This is based on one other report from a clinic (b)(6) knows.They need to however work through a process of elimination and will like to see if we have had any reports on the items listed, they are in common in the infected patients treatment cycles.I do not want to put proceed with a complaint as i do not see this as a complaint but an investigation, however, will take direction from you as to how it may best to capture the situation and also the specifics of the communication to the customer.Customer just wishes to know if any items from these lots have also been investigated for infection - no actual complaint here.Customer contact- (b)(6).Ez-squeeze and bulb 170 7-72-3170-20.E-complaint- (b)(4).

Manufacturer Narrative

Investigation : x-no sample returned: x-review dhr.*analysis and findings (b)(4).*was the complaint confirmed? no."distribution history: the complaint product was manufactured at csi on 2nd july 2020.Manufacturing record review: dhr was reviewed and no non-conformities, related to the complaint condition, were noted.No other complaints reported that relate to this lot number.Incoming inspection review: incoming inspection record review not applicable to this product.Service history record: service history not applicable for this product.Historical complaint review: a review of the 2-year complaint history did not show similar reported complaint conditions.Product receipt: the complaint product has not been returned to coopersurgical.Visual evaluation: evaluation of the complaint product could not be completed as the complaint product has not been returned to coopersurgical.If the product should be returned at a later date, it will be evaluated, and any findings will be appended to this investigation.Functional evaluation: evaluation of the complaint product could not be completed as the complaint product has not been returned to coopersurgical.If the product should be returned at a later date, it will be evaluated, and any findings will be appended to this investigation.Root cause: root cause not applicable as the complaint condition was not confirmed." *correction and/or corrective action no other complaints reported that relate to this lot number.Coopersurgical will continue to monitor this complaint condition for trends.No further corrective action is necessary, as the complaint condition was not confirmed.No further training required at this time.*preventative action activity coopersurgical will continue to monitor this complaint condition for trends.

Event Description

Multiple reports on tips & pipette submitted by csi uk.Incident detail- they have had a lab infection.This is across multiple patients.They suspect that the most likely source is the gtl media from vl.This is based on one other report from a clinic katie knows.They need to however work through a process of elimination and will like to see if we have had any reports on the items listed, they are in common in the infected patients treatment cycles.I do not want to put proceed with a complaint as i do not see this as a complaint but an investigation, however, will take direction from you as to how it may best to capture the situation and also the specifics of the communication to the customer.Customer just wishes to know if any items from these lots have also been investigated for infection - no actual complaint here.Customer contact- (b)(6).1216677-2021-00101 ez-squeeze and bulb 170 7-72-3170-20 (b)(4).

• Brand Name: EZ-SQUEEZE & BULB 170
• Type of Device: EZ-SQUEEZE & BULB 170
• Manufacturer (Section D): COOPERSURGICAL, INC.; 95 corporate drive; trumbull CT 06611
• Manufacturer (Section G): COOPERSURGICAL, INC,; 75 corporate drive; trumbull CT 06611
• Manufacturer Contact: michael marone ; 50 corporate drive; trumbull, CT 06611 ; 4752651665
• MDR Report Key: 11813541
• MDR Text Key: 262963481
• Report Number: 1216677-2021-00101
• Device Sequence Number: 1
• Product Code: MQH
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K161275
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 7-72-3170/20
• Device Catalogue Number: 7-72-3170/20
• Device Lot Number: 209920
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other