MAUDE Adverse Event Report: MALLINCKRODT DAR SRL DAR; FILTER, BACTERIAL, BREATHING-CIRCUIT

Model Number	350S19006
Medical Device Problem Code	Contamination of Device Ingredient or Reagent (2901)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, prior to use, the device had visible black spot seen with filter.The customer reported that there was no patient involvement.
Additional Manufacturer Narrative
The customer sent us one sample in its original opened packaging that showed black spots in the filter lid.Reported problem was verified.The customer complains the presence of black spots on the filter.The spots found on the plastic device are a typical molding defect.We perform an in process control with a sampling plan that for its nature allows a percentage of this kind of spot.We highlight that this kind of spot is incorporated into the (b)(4), and for this reason not risky for the patient.We underline that we run annual sessions of good manufacturing process(gmp) training to sensitize all our personnel on this kind of problem.Information has been added to the database and trends will continue to be monitored.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: DAR
• Common Device Name: FILTER, BACTERIAL, BREATHING-CIRCUIT
• Manufacturer (Section D): MALLINCKRODT DAR SRL; via giacomo bove 2/4/6/8; mirandola 41037 ; IT 41037
• MDR Report Key: 7763717
• Report Number: 2936999-2018-00495
• Device Sequence Number: 1431626
• Product Code: CAH
• UDI-Device Identifier: 40884522012981
• UDI-Public: 40884522012981
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K941536
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/03/2018

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
• Operator of Device: Health Professional
• Device Model Number: 350S19006
• Device Catalogue Number: 350S19006
• Device Lot Number: 18B0674F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2018
• Initial Date Received by Manufacturer: 07/24/2018
• Supplement Date Received by Manufacturer: 08/08/2018; 09/04/2018
• Initial Report FDA Received Date: 08/08/2018
• Supplement Report FDA Received Date: 10/02/2018; 10/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1