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

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.

• 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 Key: 11814606
• MDR Text Key: 262965995
• Report Number: 1216677-2021-00102
• 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: PP-5.75-1000PL
• Device Catalogue Number: PP-5.75-1000PL
• Device Lot Number: 286471
• 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