MAUDE Adverse Event Report: COOK INC SPHERE INFLATION DEVICE

Catalog Number	CID-20-30-NG
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Pma/510(k) number: unavailable.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.
Event or Problem Description
It was reported that a small piece of black plastic was found inside the syringe of the sphere inflation device.It appeared as if it was some debris from the plunger.The unspecified procedure was completed as planned.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence nor was any foreign material retained in the patient's anatomy.
Additional Manufacturer Narrative
Investigation/evaluation: a review of the dimensional verification, complaint history, device history record, drawing, quality control, trends, and a visual inspection and functional evaluation of the returned device were performed by the supplier as a part of the investigation.The device was forwarded to the supplier for evaluation.During the visual inspection, it was noted that there were small black particulates inside the housing of the inflator.The particulates were located inside and outside the fluid path.There were no other visual anomalies noted in the visual inspection.A clinical assessment of the reported incident was also performed as a part of the ongoing investigation.Photos from the customer show what appear to be black particles but the source and composition of the material is not known.The device is purchased packaged, labeled, and sterile per the drawing from the approved supplier.A search of the complaint database revealed this complaint to be the only reported complaint associated to the complaint lot number.Based on the information provided and the results of our investigation, the root cause was determined to be related to the device manufacturing process.We will continue to monitor for similar complaints.Per the quality engineering risk assessment, no further action is required.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.Refer to section h10 for investigation findings.

• Brand Name: SPHERE INFLATION DEVICE
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7502447
• Report Number: 1820334-2018-01230
• Device Sequence Number: 11267224
• Product Code: MAV
• UDI-Device Identifier: 10827002255712
• UDI-Public: (01)10827002255712(17)210131(10)96469013
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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
• Report Date (Section B): 09/25/2018

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 Catalogue Number: CID-20-30-NG
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/19/2018
• Supplement Date Received by Manufacturer: 09/25/2018
• Initial Report FDA Received Date: 05/10/2018
• Supplement Report FDA Received Date: 09/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1