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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOPERSURGICAL, INC. IVF PASTEUR PIPET PLUGGED

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COOPERSURGICAL, INC. IVF PASTEUR PIPET PLUGGED Back to Search Results
Model Number PP-5.75-1000PL
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).Ivf pasteur pipet plugged pp 5-75-1000pl.E-complaint- (b)(4).
 
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 (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).1216677-2021-00102 ivf pasteur pipet plugged pp 5-75-1000pl (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 purchased from a supplier (fisher scientific), packaged by csi in march 2020 under work order: (b)(4).Manufacturing record review: dhr 286741 was reviewed and no non-conformities, related to the complaint condition, were noted.Incoming inspection review: a review of the incoming inspection record could not be performed as the component part: (pp-5.75-fp) is not lot controlled.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.It should be noted that this work order had 1-cell mea and endotoxin tests conducted on the product and both tests passed.Correction and/or corrective action: no other complaints reported that relate to this lot number.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.
 
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Brand Name
IVF PASTEUR PIPET PLUGGED
Type of Device
IVF PASTEUR PIPET PLUGGED
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 Key11814606
MDR Text Key262965995
Report Number1216677-2021-00102
Device Sequence Number1
Product Code MQH
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K161275
Number of Events Reported1
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
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model NumberPP-5.75-1000PL
Device Catalogue NumberPP-5.75-1000PL
Device Lot Number286471
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received05/12/2021
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received04/05/2023
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 Number1
Patient Outcome(s) Other;
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